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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
This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 261 |
| Start date | 2006-02 |
| Completion | 2007-03 |
Conditions
- Hypertension
Interventions
- Comparator: losartan +/- HCTZ
- Comparator: Placebo
Primary outcomes
- Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 — 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 — 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 12 — 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 — 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 16 — 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. - Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16 — 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.