Trial Outcomes & Findings for An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension (NCT NCT00412932)
NCT ID: NCT00412932
Last Updated: 2009-09-22
Results Overview
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
COMPLETED
PHASE4
178 participants
baseline to 12 weeks
2009-09-22
Participant Flow
Participants were recruited at 37 US sites (private medical practices and small clinics) over 13 months (Nov 29,06 to Dec 28,07) from each physician's clientele base. Approximately 200 eligible participants, men and women at least 65 years of age with hypertension or uncontrolled hypertension on current medication, were to receive active treatment
After 3-4 weeks of placebo, patients with a systolic pressure (SBP) ≥150 ≤199mmHg and diastolic pressure (DBP) ≤109 mmHg at the last 2 visits, and 8-hr daytime SBP \>140 and ≤199 mmHg and DBP ≤109 mmHg by ambulatory blood pressure monitoring were entered.All started with Olmesartan 20 mg and were titrated if their blood pressure was not controlled
Participant milestones
| Measure |
Active Treatment Period
All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
|
|---|---|
|
Olmesartan (Olm) 20 mg
STARTED
|
178
|
|
Olmesartan (Olm) 20 mg
COMPLETED
|
171
|
|
Olmesartan (Olm) 20 mg
NOT COMPLETED
|
7
|
|
Olmesartan 40 mg
STARTED
|
169
|
|
Olmesartan 40 mg
COMPLETED
|
161
|
|
Olmesartan 40 mg
NOT COMPLETED
|
8
|
|
Olm+Hydrochlorothiazide 12.5 mg
STARTED
|
159
|
|
Olm+Hydrochlorothiazide 12.5 mg
COMPLETED
|
153
|
|
Olm+Hydrochlorothiazide 12.5 mg
NOT COMPLETED
|
6
|
|
Olm+ Hydrochlorothiazide 25 mg
STARTED
|
125
|
|
Olm+ Hydrochlorothiazide 25 mg
COMPLETED
|
123
|
|
Olm+ Hydrochlorothiazide 25 mg
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Active Treatment Period
All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
|
|---|---|
|
Olmesartan (Olm) 20 mg
Adverse Event
|
1
|
|
Olmesartan (Olm) 20 mg
Lack of Efficacy
|
2
|
|
Olmesartan (Olm) 20 mg
Protocol Violation
|
1
|
|
Olmesartan (Olm) 20 mg
Withdrawal by Subject
|
2
|
|
Olmesartan (Olm) 20 mg
Other
|
1
|
|
Olmesartan 40 mg
Adverse Event
|
4
|
|
Olmesartan 40 mg
Lack of Efficacy
|
3
|
|
Olmesartan 40 mg
Withdrawal by Subject
|
1
|
|
Olm+Hydrochlorothiazide 12.5 mg
Adverse Event
|
3
|
|
Olm+Hydrochlorothiazide 12.5 mg
Withdrawal by Subject
|
3
|
|
Olm+ Hydrochlorothiazide 25 mg
Adverse Event
|
1
|
|
Olm+ Hydrochlorothiazide 25 mg
Lost to Follow-up
|
1
|
Baseline Characteristics
An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension
Baseline characteristics by cohort
| Measure |
Active Treatment Period
n=178 Participants
All participants started the active treatment period with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40 mg Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
|
|---|---|
|
Age Continuous
|
72.0 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
178 participants
n=99 Participants
|
|
Baseline stage of hypertension
Stage 1 hypertension
|
62 participants
n=99 Participants
|
|
Baseline stage of hypertension
Stage 2 hypertension
|
116 participants
n=99 Participants
|
|
Baseline 24-hour ambulatory diastolic blood pressure
|
80.7 mm Hg
STANDARD_DEVIATION 8.5 • n=99 Participants
|
|
Baseline 24-hour ambulatory systolic blood pressure
|
149.1 mm Hg
STANDARD_DEVIATION 11.2 • n=99 Participants
|
|
Baseline diastolic blood pressure
|
87.7 mm Hg
STANDARD_DEVIATION 9.6 • n=99 Participants
|
|
Baseline heart rate
|
71.5 beats/minute
STANDARD_DEVIATION 11.4 • n=99 Participants
|
|
Baseline systolic blood pressure
|
165.5 mm Hg
STANDARD_DEVIATION 11.9 • n=99 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPopulation: 178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Outcome measures
| Measure |
Overall Study
n=150 Participants
|
|---|---|
|
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
|
-25.7 mm Hg
Standard Error 0.96
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: 178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Outcome measures
| Measure |
Overall Study
n=150 Participants
|
|---|---|
|
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.
|
-12.3 mm Hg
Standard Error 0.55
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: 178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Outcome measures
| Measure |
Overall Study
n=150 Participants
|
|---|---|
|
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
Daytime
|
-26.5 mm Hg
Standard Error 1.10
|
|
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
Nighttime
|
-24.4 mm Hg
Standard Error 1.04
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: 178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had baseline and week 12 ABPM measurements.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Outcome measures
| Measure |
Overall Study
n=150 Participants
|
|---|---|
|
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment
Daytime
|
-13.0 mm Hg
Standard Error 0.65
|
|
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment
Nighttime
|
-11.5 mm Hg
Standard Error 0.60
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: 178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Outcome measures
| Measure |
Overall Study
n=150 Participants
|
|---|---|
|
Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment
BP<140/90 mm Hg
|
133 participants
|
|
Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment
SBP<140 mm Hg
|
133 participants
|
|
Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment
DBP<90 mm Hg
|
149 participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: 178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Outcome measures
| Measure |
Overall Study
n=150 Participants
|
|---|---|
|
Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
BP<140/90 mm Hg
|
120 participants
|
|
Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
SBP<140 mm Hg
|
120 participants
|
|
Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
DBP<90 mm Hg
|
145 participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: 178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Outcome measures
| Measure |
Overall Study
n=150 Participants
|
|---|---|
|
Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
BP<140/90 mm Hg
|
143 participants
|
|
Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
SBP<140 mm Hg
|
143 participants
|
|
Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
DBP<90 mm Hg
|
149 participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee "If identified by Daiichi Sankyo, Inc. (DSI), any of DSI's confidential information as defined herein shall be deleted. Nothing in this Publication section shall be taken as giving DSI the right of editorial control over any publication prepared by the study site."
- Publication restrictions are in place
Restriction type: OTHER