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

Abbott

Status and phase: Completed; Phase 3

Conditions: Hypertension; Obesity

Treatments: Drug: sibutramine; Drug: metoprolol/HCT; Drug: verapamil/trandolapril; Drug: felodipine/ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00679653

KD200010

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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171 participants in 3 patient groups

1

Active Comparator group

Description:

verapamil/trandolapril

Treatment:

Drug: sibutramine

Drug: verapamil/trandolapril

Drug: sibutramine

2

Active Comparator group

Description:

metoprolol/HCT

Treatment:

Drug: sibutramine

Drug: metoprolol/HCT

Drug: sibutramine

3

Active Comparator group

Description:

felodipine/ramipril

Treatment:

Drug: felodipine/ramipril

Drug: sibutramine

Drug: sibutramine