Obese Hypertension Study - Full Text View

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Comparator: losartan +/- HCTZ Drug: Comparator: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Obesity Potassium

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289887

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Publications:

Oparil S, Abate N, Chen E, Creager MA, Galet V, Jia G, Julius S, Lerman A, Lyle PA, Pool J, Tershakovec AM. A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. Curr Med Res Opin. 2008 Apr;24(4):1101-14. Epub 2008 Mar 6.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00289887 History of Changes
Other Study ID Numbers:	2006_002, MK0954-315
Study First Received:	February 8, 2006
Results First Received:	September 21, 2009
Last Updated:	April 29, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Losartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 22, 2013