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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00679653 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Hypertension |
Drug: sibutramine Drug: verapamil/trandolapril Drug: metoprolol/HCT Drug: felodipine/ramipril |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives |
| Enrollment: | 171 |
| Study Start Date: | February 2002 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
verapamil/trandolapril
|
Drug: sibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
Other Names:
Drug: sibutramine
8-wks, sibutramine, 15 mg, capsules, once daily
Other Names:
Drug: verapamil/trandolapril
2 wk Run-in phase, antihypertensive therapy only
Other Name: verapamil/trandolapril
|
|
Active Comparator: 2
metoprolol/HCT
|
Drug: sibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
Other Names:
Drug: sibutramine
8-wks, sibutramine, 15 mg, capsules, once daily
Other Names:
Drug: metoprolol/HCT
2 wk Run-in phase, antihypertensive therapy only
Other Name: metoprolol/HCT
|
|
Active Comparator: 3
felodipine/ramipril
|
Drug: sibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
Other Names:
Drug: sibutramine
8-wks, sibutramine, 15 mg, capsules, once daily
Other Names:
Drug: felodipine/ramipril
2 wk Run-in phase, antihypertensive therapy only
Other Name: felodipine/ramipril
|
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Prof. Dr. Med J. Scholze, Director of Charite Medical OPD |
| ClinicalTrials.gov Identifier: | NCT00679653 History of Changes |
| Other Study ID Numbers: | KD200010 |
| Study First Received: | March 26, 2008 |
| Last Updated: | May 16, 2008 |
| Health Authority: | Germany: Ministry of Health |
|
Hypertension Obesity Vascular Diseases Cardiovascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Trandolapril Antihypertensive Agents Metoprolol Diltiazem Felodipine Ramipril |
Verapamil Metoprolol succinate Sibutramine Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
