A Double-Blind, Randomized, Parallel, Efficacy Study Evaluating Losartan Potassium Alone or in Combination With Hydrochlorothiazide Versus Placebo in Obese Patients With Elevated Systolic and Diastolic Blood Pressure
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Organon and Co
- Enrollment
- 261
- Primary Endpoint
- Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Obese male and female patients, ages 21-75 years, with high blood pressure
Exclusion Criteria
- •Patients cannot have any other severe cardiac conditions
Outcomes
Primary Outcomes
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Time Frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12
Time Frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Time Frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
Time Frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16
Time Frame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16
Time Frame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.