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| Sponsored by: |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| 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 |
|---|---|
|
1: Active Comparator
verapamil/trandolapril
|
Drug: sibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
Drug: sibutramine
8-wks, sibutramine, 15 mg, capsules, once daily
Drug: verapamil/trandolapril
2 wk Run-in phase, antihypertensive therapy only
|
|
2: Active Comparator
metoprolol/HCT
|
Drug: sibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
Drug: sibutramine
8-wks, sibutramine, 15 mg, capsules, once daily
Drug: metoprolol/HCT
2 wk Run-in phase, antihypertensive therapy only
|
|
3: Active Comparator
felodipine/ramipril
|
Drug: sibutramine
8-wks, sibutramine, 10 mg, capsules, once daily
Drug: sibutramine
8-wks, sibutramine, 15 mg, capsules, once daily
Drug: felodipine/ramipril
2 wk Run-in phase, antihypertensive therapy only
|
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: | Director of Charite Medical OPD ( Prof. Dr. Med J. Scholze ) |
| Study ID Numbers: | KD200010 |
| Study First Received: | March 26, 2008 |
| Last Updated: | May 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00679653 |
| Health Authority: | Germany: Ministry of Health |
|
Obesity Vascular Diseases Overweight Metoprolol Ramipril Body Weight Sibutramine Calcium, Dietary Signs and Symptoms |
Trandolapril Verapamil Metoprolol succinate Diltiazem Nutrition Disorders Overnutrition Felodipine Hypertension |
|
Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Psychotropic Drugs Calcium Channel Blockers Membrane Transport Modulators Therapeutic Uses Adrenergic beta-Antagonists Angiotensin-Converting Enzyme Inhibitors Appetite Depressants Cardiovascular Diseases |
Anti-Arrhythmia Agents Antidepressive Agents Sympatholytics Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Anti-Obesity Agents Autonomic Agents Adrenergic Antagonists Peripheral Nervous System Agents Central Nervous System Agents |
