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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2003

Interventions

  • Drug: sibutramine
    • 8-wks, sibutramine, 10 mg, capsules, once daily
  • Drug: sibutramine
    • 8-wks, sibutramine, 15 mg, capsules, once daily
  • Drug: verapamil/trandolapril
    • 2 wk Run-in phase, antihypertensive therapy only
  • Drug: metoprolol/HCT
    • 2 wk Run-in phase, antihypertensive therapy only
  • Drug: felodipine/ramipril
    • 2 wk Run-in phase, antihypertensive therapy only

Arms, Groups and Cohorts

  • Active Comparator: 1
    • verapamil/trandolapril
  • Active Comparator: 2
    • metoprolol/HCT
  • Active Comparator: 3
    • felodipine/ramipril

Clinical Trial Outcome Measures

Primary Measures

  • Systolic Blood Pressure
    • Time Frame: Duration of Study
  • Diastolic Blood Pressure
    • Time Frame: Duration of Study

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott
  • Provider of Information About this Clinical Study
    • Prof. Dr. Med J. Scholze, Director of Charite Medical OPD

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