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

NCT ID: NCT00679653

Last Updated: 2008-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Brief Summary

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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

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Conditions

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Obesity Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

verapamil/trandolapril

Group Type ACTIVE_COMPARATOR

sibutramine

Intervention Type DRUG

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

sibutramine

Intervention Type DRUG

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

verapamil/trandolapril

Intervention Type DRUG

2 wk Run-in phase, antihypertensive therapy only

2

metoprolol/HCT

Group Type ACTIVE_COMPARATOR

sibutramine

Intervention Type DRUG

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

sibutramine

Intervention Type DRUG

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

metoprolol/HCT

Intervention Type DRUG

2 wk Run-in phase, antihypertensive therapy only

3

felodipine/ramipril

Group Type ACTIVE_COMPARATOR

sibutramine

Intervention Type DRUG

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

sibutramine

Intervention Type DRUG

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

felodipine/ramipril

Intervention Type DRUG

2 wk Run-in phase, antihypertensive therapy only

Interventions

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sibutramine

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

Intervention Type DRUG

sibutramine

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

Intervention Type DRUG

verapamil/trandolapril

2 wk Run-in phase, antihypertensive therapy only

Intervention Type DRUG

metoprolol/HCT

2 wk Run-in phase, antihypertensive therapy only

Intervention Type DRUG

felodipine/ramipril

2 wk Run-in phase, antihypertensive therapy only

Intervention Type DRUG

Other Intervention Names

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ABT-991 Meridia Reductil ABT-991 Meridia Reductil

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Director of Charite Medical OPD

Other Identifiers

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KD200010

Identifier Type: -

Identifier Source: org_study_id