Trial Outcomes & Findings for Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone in Participants With Moderate to Severe Hypertension (NCT NCT00818883)
NCT ID: NCT00818883
Last Updated: 2012-02-07
Results Overview
The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
609 participants
Primary outcome timeframe
Baseline, Week 6 and Week 10.
Results posted on
2012-02-07
Participant Flow
Participants enrolled at 66 investigative sites in the Russian Federation and the United States from 20 January 2009 to 30 November 2009.
Participants with patients with moderate to severe essential hypertension were enrolled in one of 2, once-daily (QD) treatment groups.
Participant milestones
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
303
|
306
|
|
Overall Study
COMPLETED
|
252
|
260
|
|
Overall Study
NOT COMPLETED
|
51
|
46
|
Reasons for withdrawal
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
28
|
19
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
16
|
14
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Other
|
2
|
7
|
Baseline Characteristics
Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone in Participants With Moderate to Severe Hypertension
Baseline characteristics by cohort
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=306 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
Total
n=609 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.8 years
STANDARD_DEVIATION 10.79 • n=99 Participants
|
55.9 years
STANDARD_DEVIATION 10.97 • n=107 Participants
|
56.4 years
STANDARD_DEVIATION 10.88 • n=206 Participants
|
|
Age, Customized
<45 years
|
43 participants
n=99 Participants
|
50 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
Age, Customized
Between 45 and 64 years
|
189 participants
n=99 Participants
|
195 participants
n=107 Participants
|
384 participants
n=206 Participants
|
|
Age, Customized
≥65 years
|
71 participants
n=99 Participants
|
61 participants
n=107 Participants
|
132 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
313 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=99 Participants
|
151 Participants
n=107 Participants
|
296 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
173 Participants
n=99 Participants
|
184 Participants
n=107 Participants
|
357 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
90 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
184 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 participants
n=99 Participants
|
1 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 participants
n=99 Participants
|
38 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
252 participants
n=99 Participants
|
265 participants
n=107 Participants
|
517 participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 participants
n=99 Participants
|
0 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
213 participants
n=99 Participants
|
214 participants
n=107 Participants
|
427 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
90 participants
n=99 Participants
|
92 participants
n=107 Participants
|
182 participants
n=206 Participants
|
|
Estimated glomerular filtration rate (eGFR)
Moderate impairment
|
23 participants
n=99 Participants
|
24 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Estimated glomerular filtration rate (eGFR)
Mild impairment
|
180 participants
n=99 Participants
|
184 participants
n=107 Participants
|
364 participants
n=206 Participants
|
|
Estimated glomerular filtration rate (eGFR)
Normal
|
100 participants
n=99 Participants
|
98 participants
n=107 Participants
|
198 participants
n=206 Participants
|
|
Weight
|
87.60 kg
STANDARD_DEVIATION 19.181 • n=99 Participants
|
90.61 kg
STANDARD_DEVIATION 19.252 • n=107 Participants
|
89.11 kg
STANDARD_DEVIATION 19.260 • n=206 Participants
|
|
Height
|
168.9 cm
STANDARD_DEVIATION 10.08 • n=99 Participants
|
168.8 cm
STANDARD_DEVIATION 9.69 • n=107 Participants
|
168.9 cm
STANDARD_DEVIATION 9.88 • n=206 Participants
|
|
Body Mass Index (BMI)
|
30.7 kg/m2
STANDARD_DEVIATION 6.12 • n=99 Participants
|
31.8 kg/m2
STANDARD_DEVIATION 6.10 • n=107 Participants
|
31.2 kg/m2
STANDARD_DEVIATION 6.13 • n=206 Participants
|
|
Chronic Kidney Disease (CKD) Status
|
24 participants
n=99 Participants
|
24 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Diabetes status
|
31 participants
n=99 Participants
|
35 participants
n=107 Participants
|
66 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure
Week 6 (n=295; n=292)
|
-35.1 mmHg
Standard Error 0.97
|
-29.5 mmHg
Standard Error 0.98
|
|
Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure
Week 10 (n=295; n=292)
|
-37.8 mmHg
Standard Error 0.91
|
-32.8 mmHg
Standard Error 0.91
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in sitting trough clinic diastolic blood pressure measured at each week indicated including final visit relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure
Week 6 (n=295; n=292)
|
-15.0 mmHg
Standard Error 0.55
|
-11.2 mmHg
Standard Error 0.55
|
|
Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure
Week 10 (n=295; n=292)
|
-16.4 mmHg
Standard Error 0.50
|
-13.7 mmHg
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in trough systolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.
Week 6 (n=179, n=162)
|
-25.7 mmHg
Standard Error 1.11
|
-18.4 mmHg
Standard Error 1.16
|
|
Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.
Week 10 (n=227, n=230)
|
-25.6 mmHg
Standard Error 0.91
|
-21.4 mmHg
Standard Error 0.90
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in trough diastolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.
Week 6 (n=179; n=162)
|
-15.2 mmHg
Standard Error 0.70
|
-10.6 mmHg
Standard Error 0.74
|
|
Change From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.
Week 10 (n=227; n=230)
|
-15.1 mmHg
Standard Error 0.63
|
-12.7 mmHg
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in 24-hour mean systolic blood pressure measured at each visit indicated including final visit 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/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 6 (n=179, n=162)
|
-25.7 mmHg
Standard Error 0.92
|
-19.9 mmHg
Standard Error 0.97
|
|
Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 10 (n=227, n=230)
|
-26.6 mmHg
Standard Error 0.80
|
-22.4 mmHg
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in 24-hour mean diastolic blood pressure measured at each visit indicated including final visit 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/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 6 (n=179; n=162)
|
-14.7 mmHg
Standard Error 0.59
|
-10.9 mmHg
Standard Error 0.62
|
|
Change From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 10 (n=227; n=230)
|
-15.2 mmHg
Standard Error 0.53
|
-12.6 mmHg
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in daytime (6am to 10pm) mean systolic blood pressure measured at each visit including final visit 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/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 6 (n=179; n=162)
|
-27.0 mmHg
Standard Error 0.95
|
-20.2 mmHg
Standard Error 1.00
|
|
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 10 (n=227; n=230)
|
-27.5 mmHg
Standard Error 0.82
|
-22.8 mmHg
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at each visit including final visit 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/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 6 (n=179; n=162)
|
-15.4 mmHg
Standard Error 0.62
|
-11.1 mmHg
Standard Error 0.65
|
|
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 10 (n=227; n=230)
|
-15.8 mmHg
Standard Error 0.55
|
-12.9 mmHg
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in nighttime (12am to 6am) mean systolic blood pressure measured at each visit indicated including final visit 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/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 10 (n=227; n=230)
|
-23.8 mmHg
Standard Error 0.87
|
-21.1 mmHg
Standard Error 0.87
|
|
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 6 (n=179; n=162)
|
-21.8 mmHg
Standard Error 0.98
|
-18.8 mmHg
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at each visit indicated including final visit 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/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 6 (n=179; n=162)
|
-12.8 mmHg
Standard Error 0.64
|
-10.3 mmHg
Standard Error 0.67
|
|
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.
Week 10 (n=227; n=230)
|
-13.8 mmHg
Standard Error 0.60
|
-11.9 mmHg
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in the 12-hour mean systolic blood pressure measured at each visit including final visit 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/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring
Week 6 (n=179; n=162)
|
-27.7 mmHg
Standard Error 0.99
|
-20.6 mmHg
Standard Error 1.04
|
|
Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring
Week 10 (n=227; n=230)
|
-28.0 mmHg
Standard Error 0.86
|
-23.2 mmHg
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
The change in the 12-hour mean diastolic blood pressure measured at each visit including final visit 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/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring.
Week 6 (n=179; n=162)
|
-15.7 mmHg
Standard Error 0.65
|
-11.1 mmHg
Standard Error 0.68
|
|
Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring.
Week 10 (n=227; n=230)
|
-16.0 mmHg
Standard Error 0.59
|
-12.9 mmHg
Standard Error 0.58
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 6, Week 8 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as \<140mm Hg without diabetes or chronic kidney disease or \<130/mm Hg with diabetes or chronic kidney disease. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease
Week 2 (n=283; n=276)
|
33.2 percentage of participants
|
34.1 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease
Week 4 (n=292; n=289)
|
68.2 percentage of participants
|
54.7 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease
Week 6 (n=295; n=292)
|
71.9 percentage of participants
|
58.2 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease
Week 8 (n=295; n=292)
|
79.7 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease
Week 10 (n=295; n=292)
|
76.9 percentage of participants
|
69.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 6, Week 8 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as \<90 mm Hg for participants without diabetes or chronic kidney disease or \<80 mm Hg for participants with diabetes or chronic kidney disease. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.
Week 2 (n=283; n=276)
|
49.1 percentage of participants
|
41.3 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.
Week 4 (n=292; n=289)
|
71.9 percentage of participants
|
57.4 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.
Week 6 (n=295; n=292)
|
76.6 percentage of participants
|
59.2 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.
Week 8 (n=295; n=292)
|
81.4 percentage of participants
|
72.3 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.
Week 10 (n=295; n=292)
|
82.7 percentage of participants
|
75.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 6, Week 8 and Week 10.Population: Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at each week indicated, defined as \<140/90 mm Hg for participants without diabetes or chronic kidney disease or \<130/80 mm Hg for participants with diabetes or chronic kidney disease\[GFR \<60 mL/min/1.73 m2 or urinary albumin:creatinine ratio (UACR) \>200 mg albumin/g creatinine at Screening.\] Systolic/diastolic blood pressure is the average of the 3 serial trough sitting systolic/diastolic blood pressure measurements.
Outcome measures
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
n=302 Participants
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease
Week 2 (n=283; n=276)
|
27.2 percentage of participants
|
24.6 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease
Week 4 (n=292; n=289)
|
58.6 percentage of participants
|
45.3 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease
Week 6 (n=295; n=292)
|
64.1 percentage of participants
|
45.9 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease
Week 8 (n=295; n=292)
|
72.5 percentage of participants
|
59.2 percentage of participants
|
|
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease
Week 10 (n=295; n=292)
|
71.5 percentage of participants
|
62.3 percentage of participants
|
Adverse Events
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
Serious events: 6 serious events
Other events: 79 other events
Deaths: 0 deaths
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
Serious events: 5 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD
n=302 participants at risk
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.33%
1/302 • 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%
0/303 • 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 occlusion
|
0.33%
1/302 • 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%
0/303 • 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 stenosis
|
0.33%
1/302 • 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%
0/303 • 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
Gastrointestinal haemorrhage
|
0.33%
1/302 • 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%
0/303 • 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
Sudden death
|
0.33%
1/302 • 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.
|
0.33%
1/303 • 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 discomfort
|
0.33%
1/302 • 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%
0/303 • 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%
0/302 • 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.
|
0.33%
1/303 • 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
Pneumonia
|
0.00%
0/302 • 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.
|
0.33%
1/303 • 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.
|
|
Investigations
Blood creatinine increased
|
0.33%
1/302 • 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%
0/303 • 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)
Breast cancer
|
0.33%
1/302 • 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%
0/303 • 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
Cerebrovascular accident
|
0.00%
0/302 • 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.
|
0.33%
1/303 • 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
Syncope
|
0.00%
0/302 • 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.
|
0.33%
1/303 • 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 failure acute
|
0.00%
0/302 • 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.
|
0.33%
1/303 • 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 failure chronic
|
0.33%
1/302 • 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%
0/303 • 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
Pulmonary embolism
|
0.00%
0/302 • 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.
|
0.33%
1/303 • 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/Chlorthalidone 12.5 mg QD
n=302 participants at risk
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment.
|
Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD
n=303 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment.
|
|---|---|---|
|
Investigations
Blood creatinine increased
|
12.6%
38/302 • 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.
|
8.9%
27/303 • 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
|
12.3%
37/302 • 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.
|
10.6%
32/303 • 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
|
5.3%
16/302 • 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%
16/303 • 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 The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER