Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives (HOS)

May 16, 2008 updated by: Abbott
To study the effect of sibutramine treatment on weight reduction and blood pressure improvement in three groups with antihypertensive therapy whose blood pressure was not adequately controlled with antihypertensive combination treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

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

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treated essential hypertension.
  • Obesity: BMI 27-35 kg/m2

Exclusion Criteria:

  • Secondary hypertension.
  • Stage 3 hypertension.
  • Secondary obesity; BMI > 35kg/m2.
  • CAD; MI within past 6 months; NYHA stage 3 or 4 heart failure; tachyarrhythmia/atrial fibrillation; myocarditis.
  • Kidney failure.
  • Liver failure.
  • Hyperthyroidism.
  • Unstable DM.
  • Carcinoma.
  • Severe chronic infectious disease.
  • Alcohol or drug abuse.
  • Pregnancy.
  • Epilepsy.
  • Psychosis or treatment with antidepressants or major tranquilizers

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
verapamil/trandolapril
Drug: sibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
Other Names:
  • ABT-991
  • Meridia
  • Reductil
Drug: sibutramine
8-wks, sibutramine, 15 mg, capsules, once daily
Other Names:
  • ABT-991
  • Meridia
  • Reductil
Drug: verapamil/trandolapril
2 wk Run-in phase, antihypertensive therapy only
ACTIVE_COMPARATOR: 2
metoprolol/HCT
Drug: sibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
Other Names:
  • ABT-991
  • Meridia
  • Reductil
Drug: sibutramine
8-wks, sibutramine, 15 mg, capsules, once daily
Other Names:
  • ABT-991
  • Meridia
  • Reductil
Drug: metoprolol/HCT
2 wk Run-in phase, antihypertensive therapy only
ACTIVE_COMPARATOR: 3
felodipine/ramipril
Drug: sibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
Other Names:
  • ABT-991
  • Meridia
  • Reductil
Drug: sibutramine
8-wks, sibutramine, 15 mg, capsules, once daily
Other Names:
  • ABT-991
  • Meridia
  • Reductil
Drug: felodipine/ramipril
2 wk Run-in phase, antihypertensive therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systolic Blood Pressure
Time Frame: Duration of Study
Duration of Study
Diastolic Blood Pressure
Time Frame: Duration of Study
Duration of Study

Collaborators and Investigators

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

Sponsor

Abbott

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, 2002

Primary Completion (ACTUAL)

December 1, 2003

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (ESTIMATE)

May 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2008

Last Update Submitted That Met QC Criteria

May 16, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD200010

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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