Obese Hypertension Study (0954-315)

February 7, 2022 updated by: Organon and Co

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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
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.
At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

February 8, 2006

First Submitted That Met QC Criteria

February 8, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0954-315
  • MK0954-315
  • 2006_002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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