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Completed

NCT Number: NCT00289887

Obese Hypertension Study (0954-315)

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: losartan +/- HCTZ

Drug

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.

Comparator: placebo

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 10, 2006
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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