Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives
Overview[ - collapse ][ - ]
| 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 | Obesity Hypertension |
| Intervention | Drug: sibutramine Drug: sibutramine Drug: verapamil/trandolapril Drug: metoprolol/HCT Drug: felodipine/ramipril |
| Phase | Phase 3 |
| Sponsor | Abbott |
| Responsible Party | Abbott |
| ClinicalTrials.gov Identifier | NCT00679653 |
| First Received | March 26, 2008 |
| Last Updated | May 16, 2008 |
| Last verified | May 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 26, 2008 |
|---|---|
| Last Updated Date | May 16, 2008 |
| Start Date | February 2002 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives |
|---|---|
| Official Title | Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: sibutramine 8-wks, sibutramine, 10 mg, capsules, once daily Other Names:
8-wks, sibutramine, 15 mg, capsules, once daily Other Names:
2 wk Run-in phase, antihypertensive therapy only Other Names: verapamil/trandolaprilDrug: metoprolol/HCT 2 wk Run-in phase, antihypertensive therapy only Other Names: metoprolol/HCTDrug: felodipine/ramipril 2 wk Run-in phase, antihypertensive therapy only Other Names: felodipine/ramipril |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 171 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | December 2003 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00679653 |
|---|---|
| Other Study ID Numbers | KD200010 |
| Has Data Monitoring Committee | No |
| Information Provided By | Abbott |
| Study Sponsor | Abbott |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | May 2008 |