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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Sibutramine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.