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

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:	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

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:

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 ]

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

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

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 History of Changes
Health Authority:	Germany: Ministry of Health

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Overweight
Ramipril
Membrane Transport Modulators
Body Weight
Sibutramine
Signs and Symptoms
Therapeutic Uses
Appetite Depressants

Angiotensin-Converting Enzyme Inhibitors
Nutrition Disorders
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antidepressive Agents
Obesity
Sympatholytics
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Metoprolol
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 09, 2009