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Obese Hypertension Study (0954-315)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: Comparator: losartan +/- HCTZ Drug: Comparator: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
- 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 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 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.
- 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.
| Enrollment: | 261 |
| Study Start Date: | February 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Losartan
|
Drug: Comparator: losartan +/- HCTZ
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.
|
|
Placebo Comparator: 2
Placebo
|
Drug: Comparator: Placebo
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.
|
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00289887
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Additional Information:
Publications:
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00289887 History of Changes |
| Other Study ID Numbers: |
0954-315 MK0954-315 2006_002 |
| Study First Received: | February 8, 2006 |
| Results First Received: | September 21, 2009 |
| Last Updated: | July 21, 2015 |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Losartan Antihypertensive Agents Diuretics Natriuretic Agents |
Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on August 18, 2017