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


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


  • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.