Obese Hypertension Study (0954-315)

Study Overview
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Brief Summary
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This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Comparator: losartan +/- HCTZ
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Losartan | Drug: Comparator: losartan +/- HCTZ<br>* Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: Placebo<br>* Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 | 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. | 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 Sitting Diastolic Blood Pressure (SiDBP) at Week 8 | 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. | 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 Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | 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. | 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 Sitting Systolic Blood Pressure (SiSBP) at Week 12 | 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. | 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 Sitting Systolic Blood Pressure (SiSBP) at Week 16 | 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. | 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 Sitting Diastolic Blood Pressure (SiDBP) at Week 16 | 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. | At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |