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

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00679653

First received: March 26, 2008

Last updated: May 16, 2008

Last verified: May 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	March 26, 2008
Last Updated Date	May 16, 2008
Start Date ^ICMJE	February 2002
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 16, 2008)	Systolic Blood Pressure [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ] Diastolic Blood Pressure [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00679653 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Obesity Hypertension
Intervention ^ICMJE	Drug: sibutramine 8-wks, sibutramine, 10 mg, capsules, once daily Other Names: ABT-991 Meridia Reductil sibutramine Drug: sibutramine 8-wks, sibutramine, 15 mg, capsules, once daily Other Names: ABT-991 Meridia Reductil sibutramine Drug: verapamil/trandolapril 2 wk Run-in phase, antihypertensive therapy only Other Name: verapamil/trandolapril Drug: metoprolol/HCT 2 wk Run-in phase, antihypertensive therapy only Other Name: metoprolol/HCT Drug: felodipine/ramipril 2 wk Run-in phase, antihypertensive therapy only Other Name: felodipine/ramipril
Study Arm (s)	Active Comparator: 1 verapamil/trandolapril Interventions: Drug: sibutramine Drug: sibutramine Drug: verapamil/trandolapril Active Comparator: 2 metoprolol/HCT Interventions: Drug: sibutramine Drug: sibutramine Drug: metoprolol/HCT Active Comparator: 3 felodipine/ramipril Interventions: Drug: sibutramine Drug: sibutramine Drug: felodipine/ramipril
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	171
Completion Date	Not Provided
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00679653
Other Study ID Numbers ^ICMJE	KD200010
Has Data Monitoring Committee	No
Responsible Party	Prof. Dr. Med J. Scholze, Director of Charite Medical OPD
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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