Obese Hypertension Study (0954-315) - 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 Sharp & Dohme Corp.:

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

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, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

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. doi: 10.1185/030079908X280716 . Epub 2008 Mar 6.


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:	November 25, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Hypertension Cardiovascular Diseases Vascular Diseases Hydrochlorothiazide Losartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Anti-Arrhythmia Agents Antihypertensive Agents	Cardiovascular Agents Diuretics Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Natriuretic Agents Pharmacologic Actions Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015