A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients. - Full Text View

Purpose

The purpose of the study is to determine the long term impact of treating overweight and obese patients with sibutramine who have a history of cardiovascular disease.

Condition	Intervention	Phase
Obesity	Drug: sibutramine hydochloride monohydrate Drug: placebo Behavioral: Diet and Exercise Counseling	Phase III

MedlinePlus related topics:

Obesity

ChemIDplus related topics:

Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event

Further study details as provided by Abbott:

Primary Outcome Measures:

Time from randomization to the first occurrence of any Cardiovascular Outcome Event. [ Time Frame: Through duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time from randomization to onset of each of protocol specified events; All-cause Mortality. [ Time Frame: Through duration of study ] [ Designated as safety issue: Yes ]

Enrollment:	10783
Study Start Date:	December 2002
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: sibutramine hydochloride monohydrate 10 mg QD Behavioral: Diet and Exercise Counseling every visit
2: Placebo Comparator	Drug: placebo 1 tablet QD Behavioral: Diet and Exercise Counseling every visit

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject's BMI is > 27 kg/m and < 45 kg/m or their BMI is > 25 kg/m and < 27 kg/m with waist circumference of > 102 cm in males or > 88 cm in females.
Medical history positive for:
- Cardiovascular disease
- Type 2 diabetes disease

Exclusion Criteria:

History of recent myocardial infarction.
Heart failure symptoms greater than NYHA Functional Class II.
Hemodynamically significant valvular or left ventricular (LV) tract obstruction.
Subjects without a pacemaker and with any of the following:
- Sinus bradycardia (< 50 bpm)
- Sick sinus syndrome
- AV block of more than 1st degree
Mean sitting systolic blood pressure (SBP) >160 mmHg. Mean sitting diastolic blood pressure (DBP) > 100 mmHg. Mean sitting heart rate (HR) > 100 bpm.
Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias.
Planned cardiac surgery or coronary angioplasty.
History of recent stroke or transient ischemic attack (TIA).
Hyperthyroidism.
Known chronic liver disease or end stage/severe renal disease.
Severe, symptomatic benign prostatic hyperplasia which may require surgery.
Known pheochromocytoma, narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).
Concomitant use of MAOIs or drugs which increase levels of serotonin in the brain.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234832

Locations


United States, Illinois
	Global Medical Information - Abbott
	North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Global Medical Information	Abbott

More Information

Responsible Party:	Abbott ( Peter Bacher, MD, PhD )
Study ID Numbers:	M01-392
First Received:	September 13, 2005
Last Updated:	October 11, 2008
ClinicalTrials.gov Identifier:	NCT00234832
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott:

Obesity

Sibutramine

Study placed in the following topic categories:

Sibutramine

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overnutrition

Overweight

Additional relevant MeSH terms:

Anti-Obesity Agents

Therapeutic Uses

Psychotropic Drugs

Appetite Depressants

Central Nervous System Agents

Antidepressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00234832