Obese Hypertension Study (0954-315)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00289887 |
Recruitment Status :
Completed
First Posted : February 10, 2006
Results First Posted : May 27, 2010
Last Update Posted : July 28, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Comparator: losartan +/- HCTZ Drug: Comparator: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 261 participants |
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 |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | February 2007 |
Actual Study Completion Date : | March 2007 |

Arm | Intervention/treatment |
---|---|
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. |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289887
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00289887 |
Other Study ID Numbers: |
0954-315 MK0954-315 2006_002 |
First Posted: | February 10, 2006 Key Record Dates |
Results First Posted: | May 27, 2010 |
Last Update Posted: | July 28, 2015 |
Last Verified: | July 2015 |
Hypertension Vascular Diseases Cardiovascular Diseases Losartan Anti-Arrhythmia Agents |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |