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

Phase 3

Completed

• Conditions: Obesity; Hypertension
• Interventions: Drug: sibutramine; Drug: verapamil/trandolapril; Drug: metoprolol/HCT; Drug: felodipine/ramipril

• Registration Number: NCT00679653
• Lead Sponsor: Abbott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2003-12
• Study First Submitted: 2008-03-26
• Status Verified: 2008-05
• Study First Submitted QC: 2008-05-16
• Last Update Submitted: 2008-05-16
• Study First Posted: 2008-05-19
• Last Update Posted: 2008-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	verapamil/trandolapril	verapamil/trandolapril
2	metoprolol/HCT	metoprolol/HCT
3	felodipine/ramipril	felodipine/ramipril
3	sibutramine	felodipine/ramipril
1	sibutramine	verapamil/trandolapril
2	sibutramine	metoprolol/HCT

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	Duration of Study
Diastolic Blood Pressure	Duration of Study