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

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.

Study Type: Interventional

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

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: sibutramine hydochloride monohydrate
  • 10 mg QD
• Drug: placebo
  • 1 tablet QD
• Behavioral: Diet and Exercise Counseling
  • every visit

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• Time from randomization to the first occurrence of any CV Outcome Event.
  • Time Frame: Through duration of study
    Safety Issue?: Yes

Secondary Measures

• Time from randomization to onset of each of protocol specified events; All-cause Mortality.
  • Time Frame: Through duration of study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Global Medical Information Study Director Abbott  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234832

Study ID Number: M01-392

ClinicalTrials.gov Identifier: NCT00234832

Health Authority: Germany: Federal Institute for Drugs and Medical Devices