Hypertension, Obesity
Conditions
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.
Interventions
DRUGsibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
DRUGverapamil/trandolapril
2 wk Run-in phase, antihypertensive therapy only
DRUGmetoprolol/HCT
2 wk Run-in phase, antihypertensive therapy only
DRUGfelodipine/ramipril
2 wk Run-in phase, antihypertensive therapy only
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic Blood Pressure | Duration of Study |
| Diastolic Blood Pressure | Duration of Study |
Outcome results
None listed