Official Title: “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: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Study Primary Completion Date: December 2003

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

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

Primary Measures

• Systolic Blood Pressure
  • Time Frame: Duration of Study
    Safety Issue?: Yes
• Diastolic Blood Pressure
  • Time Frame: Duration of Study
    Safety Issue?: Yes

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00679653

Study ID Number: KD200010

ClinicalTrials.gov Identifier: NCT00679653

Health Authority: Germany: Ministry of Health