Trial Outcomes & Findings for Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension (NCT NCT00591578)
NCT ID: NCT00591578
Last Updated: 2012-02-02
Results Overview
The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
984 participants
Primary outcome timeframe
Baseline and Week 24.
Results posted on
2012-02-02
Participant Flow
Participants enrolled at 103 investigative sites from 09 November 2007 to 03 September 2009 (double-blind phase) and 04 March 2009 to 13 March 2010 (open-label extension phase). A total of 984 participants were randomized into the double-blind treatment phase, of which 170 participants entered into the open-label extension phase.
Participants with essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
Participant milestones
| Measure |
Azilsartan Medoxomil 40 mg QD
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Valsartan 320 mg QD
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
|---|---|---|---|
|
Double-Blind Treatment Phase
STARTED
|
327
|
329
|
328
|
|
Double-Blind Treatment Phase
COMPLETED
|
249
|
249
|
244
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
78
|
80
|
84
|
|
Open-Label Extension Phase
STARTED
|
55
|
115
|
0
|
|
Open-Label Extension Phase
COMPLETED
|
49
|
105
|
0
|
|
Open-Label Extension Phase
NOT COMPLETED
|
6
|
10
|
0
|
Reasons for withdrawal
| Measure |
Azilsartan Medoxomil 40 mg QD
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Azilsartan Medoxomil 80 mg QD
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Valsartan 320 mg QD
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
|---|---|---|---|
|
Double-Blind Treatment Phase
Adverse Event
|
20
|
26
|
19
|
|
Double-Blind Treatment Phase
Protocol Violation
|
3
|
2
|
3
|
|
Double-Blind Treatment Phase
Lost to Follow-up
|
12
|
12
|
11
|
|
Double-Blind Treatment Phase
Withdrawal by Subject
|
22
|
22
|
22
|
|
Double-Blind Treatment Phase
Pregnancy
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Lack of Efficacy
|
16
|
9
|
25
|
|
Double-Blind Treatment Phase
Other
|
4
|
9
|
4
|
|
Open-Label Extension Phase
Adverse Event
|
3
|
5
|
0
|
|
Open-Label Extension Phase
Lost to Follow-up
|
1
|
4
|
0
|
|
Open-Label Extension Phase
Withdrawal by Subject
|
1
|
1
|
0
|
|
Open-Label Extension Phase
Other
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension
Baseline characteristics by cohort
| Measure |
Azilsartan Medoxomil 40 mg QD
n=327 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Azilsartan Medoxomil 80 mg QD
n=329 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Valsartan 320 mg QD
n=328 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Total
n=984 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 years (Double Blind Phase)
|
43 participants
n=99 Participants
|
39 participants
n=107 Participants
|
31 participants
n=206 Participants
|
113 participants
n=7 Participants
|
|
Age, Customized
Between 45 and 64 years (Double Blind Phase)
|
181 participants
n=99 Participants
|
208 participants
n=107 Participants
|
199 participants
n=206 Participants
|
588 participants
n=7 Participants
|
|
Age, Customized
≥65 years (Double Blind Phase)
|
103 participants
n=99 Participants
|
82 participants
n=107 Participants
|
98 participants
n=206 Participants
|
283 participants
n=7 Participants
|
|
Age, Customized
<45 years (Open Label Phase)
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
0 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Age, Customized
Between 45 and 64 years (Open Label Phase)
|
25 participants
n=99 Participants
|
68 participants
n=107 Participants
|
0 participants
n=206 Participants
|
93 participants
n=7 Participants
|
|
Age, Customized
≥65 years (Open Label Phase)
|
20 participants
n=99 Participants
|
39 participants
n=107 Participants
|
0 participants
n=206 Participants
|
59 participants
n=7 Participants
|
|
Sex/Gender, Customized
Female (Double Blind Phase)
|
163 participants
n=99 Participants
|
160 participants
n=107 Participants
|
152 participants
n=206 Participants
|
475 participants
n=7 Participants
|
|
Sex/Gender, Customized
Male (Double Blind Phase)
|
164 participants
n=99 Participants
|
169 participants
n=107 Participants
|
176 participants
n=206 Participants
|
509 participants
n=7 Participants
|
|
Sex/Gender, Customized
Female (Open Label Phase)
|
34 participants
n=99 Participants
|
57 participants
n=107 Participants
|
0 participants
n=206 Participants
|
91 participants
n=7 Participants
|
|
Sex/Gender, Customized
Male (Open Label Phase)
|
21 participants
n=99 Participants
|
58 participants
n=107 Participants
|
0 participants
n=206 Participants
|
79 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-14.93 mmHg
Standard Error 0.698
|
-15.32 mmHg
Standard Error 0.715
|
-11.29 mmHg
Standard Error 0.707
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=323 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=311 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=322 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.
|
-14.86 mmHg
Standard Error 0.948
|
-16.92 mmHg
Standard Error 0.966
|
-11.59 mmHg
Standard Error 0.949
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-9.23 mmHg
Standard Error 0.459
|
-9.77 mmHg
Standard Error 0.470
|
-7.07 mmHg
Standard Error 0.465
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=323 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=311 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=322 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure
|
-7.16 mmHg
Standard Error 0.554
|
-7.41 mmHg
Standard Error 0.565
|
-4.65 mmHg
Standard Error 0.555
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-15.39 mmHg
Standard Error 0.732
|
-15.80 mmHg
Standard Error 0.749
|
-11.91 mmHg
Standard Error 0.741
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-9.61 mmHg
Standard Error 0.493
|
-10.11 mmHg
Standard Error 0.504
|
-7.44 mmHg
Standard Error 0.499
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-13.31 mmHg
Standard Error 0.777
|
-13.95 mmHg
Standard Error 0.795
|
-9.52 mmHg
Standard Error 0.786
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-8.06 mmHg
Standard Error 0.526
|
-8.90 mmHg
Standard Error 0.539
|
-6.06 mmHg
Standard Error 0.533
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-15.64 mmHg
Standard Error 0.764
|
-16.20 mmHg
Standard Error 0.782
|
-12.20 mmHg
Standard Error 0.774
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in the 12-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-9.70 mmHg
Standard Error 0.522
|
-10.26 mmHg
Standard Error 0.534
|
-7.53 mmHg
Standard Error 0.528
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-13.74 mmHg
Standard Error 0.851
|
-13.83 mmHg
Standard Error 0.871
|
-10.36 mmHg
Standard Error 0.861
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=284 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=271 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=277 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
|
-9.37 mmHg
Standard Error 0.617
|
-9.65 mmHg
Standard Error 0.632
|
-7.06 mmHg
Standard Error 0.625
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
Percentage of participants who achieve a clinic systolic blood pressure response measured at week 24, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=323 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=311 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=322 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg.
|
56.0 percentage of participants
|
59.2 percentage of participants
|
46.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=323 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=311 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=322 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg.
|
72.4 percentage of participants
|
74.0 percentage of participants
|
65.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Full analysis set with last observation carried forward.
Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg QD
n=323 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
|
Azilsartan Medoxomil 80 mg QD
n=311 Participants
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
|
Valsartan 320 mg QD
n=322 Participants
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.
|
50.2 percentage of participants
|
54.7 percentage of participants
|
41.3 percentage of participants
|
Adverse Events
Azilsartan Medoxomil 40 mg QD
Serious events: 8 serious events
Other events: 77 other events
Deaths: 0 deaths
Azilsartan Medoxomil 80 mg QD
Serious events: 5 serious events
Other events: 74 other events
Deaths: 0 deaths
Valsartan 320 mg QD
Serious events: 8 serious events
Other events: 53 other events
Deaths: 0 deaths
Open Label Extension
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azilsartan Medoxomil 40 mg QD
n=327 participants at risk
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Azilsartan Medoxomil 80 mg QD
n=329 participants at risk
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Valsartan 320 mg QD
n=326 participants at risk
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
Open Label Extension
n=170 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, independent of participant's double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
|---|---|---|---|---|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.30%
1/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.31%
1/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.31%
1/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.30%
1/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.59%
1/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.31%
1/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.30%
1/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.59%
1/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.31%
1/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Hepatitis A
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.31%
1/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.31%
1/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.31%
1/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.30%
1/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.30%
1/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Arteriosclerosis
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.31%
1/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.31%
1/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.59%
1/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.59%
1/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Azilsartan Medoxomil 40 mg QD
n=327 participants at risk
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Azilsartan Medoxomil 80 mg QD
n=329 participants at risk
Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
Valsartan 320 mg QD
n=326 participants at risk
Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
|
Open Label Extension
n=170 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, independent of participant's double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (\<140/90 mm Hg or \<130/80 mm Hg for diabetics).
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
8.0%
26/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.6%
25/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.9%
16/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
10/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
8.3%
27/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.8%
29/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.6%
15/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.7%
8/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
10.1%
33/327 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.8%
29/329 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.6%
28/326 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
9/170 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER