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

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
Original Secondary Outcome Measures ^ICMJE

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
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition ^ICMJE	Obesity Hypertension
Intervention ^ICMJE	Drug: sibutramine Drug: verapamil/trandolapril Drug: metoprolol/HCT Drug: felodipine/ramipril
Study Arms / Comparison Groups	Active Comparator: verapamil/trandolapril Active Comparator: metoprolol/HCT Active Comparator: felodipine/ramipril
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	171
Completion Date
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

Administrative Information
NCT ID ^ICMJE	NCT00679653
Responsible Party	Prof. Dr. Med J. Scholze, Director of Charite Medical OPD
Study ID Numbers ^ICMJE	KD200010
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
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