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

A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients. (SCOUT)

This study has been completed.

First Received: September 13, 2005 Last Updated: April 17, 2009 History of Changes

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

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 hydrochloride monohydrate Drug: placebo Behavioral: Diet and Exercise Counseling	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Diets Obesity

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

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
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: sibutramine hydrochloride 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

No publications provided

Responsible Party:	Abbott ( Peter Bacher, MD, PhD )
Study ID Numbers:	M01-392
Study First Received:	September 13, 2005
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00234832 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott:

Obesity
Sibutramine

Additional relevant MeSH terms:

Obesity
Psychotropic Drugs
Overweight
Pharmacologic Actions
Body Weight
Sibutramine
Signs and Symptoms
Anti-Obesity Agents

Therapeutic Uses
Nutrition Disorders
Appetite Depressants
Cardiovascular Diseases
Overnutrition
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010