Status:
COMPLETED
A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients
Lead Sponsor:
Abbott
Conditions:
Obesity
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.
Detailed Description
The study consisted of 4 periods: 1) a Screening Period of approximately 2 weeks; 2) a 6-week Lead-in Period, during which subjects received single-blind sibutramine and country-specific standard of c...
Eligibility Criteria
Inclusion
- Subject's body mass index (BMI) was \>= 27 kg/m(2) and \<= 45 kg/m(2) or their BMI was \>= 25 kg/m(2) and \< 27 kg/m(2) with waist circumference of \>= 102 cm in males or \>= 88 cm in females.
- Medical history positive for:
- Preexisting cardiovascular disease (i.e., coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease) and/or
- Type 2 diabetes mellitus with at least 1 other risk factor (i.e., dyslipidemia, controlled hypertension, current smoker, or diabetic nephropathy with evidence of microalbuminuria)
Exclusion
- History of recent myocardial infarction.
- Heart failure symptoms greater than New York Heart Association 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
- Atrioventricular 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 within 6 months of screening.
- History of recent non-hemorrhagic stroke or transient ischemic attack (TIA), history of hemorrhagic stroke.
- Hyperthyroidism.
- Known chronic liver disease or endstage renal disease.
- Severe, symptomatic benign prostatic hyperplasia which may require surgery.
- Known pheochromocytoma, history of narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).
- Concomitant use of monoamine oxidase inhibitors or drugs that increase levels of serotonin in the brain.
- Treated hypertension stabilized for less than 3 months.
- Inability to perform regular physical activity.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
10777 Patients enrolled
Trial Details
Trial ID
NCT00234832
Start Date
January 1 2003
End Date
November 1 2009
Last Update
May 11 2010
Active Locations (1)
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1
Global Medical Services
North Chicago, Illinois, United States, 60064