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

Abbott171 enrolled

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

171

Conditions

Obesity Hypertension

Interventions

sibutramineDRUG

8-wks, sibutramine, 10 mg, capsules, once daily

sibutramineDRUG

8-wks, sibutramine, 15 mg, capsules, once daily

verapamil/trandolaprilDRUG

2 wk Run-in phase, antihypertensive therapy only

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Systolic Blood Pressure

Time frame: Duration of Study

Diastolic Blood Pressure

Time frame: Duration of Study

Data from ClinicalTrials.gov

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