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

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00234832

Run by

Abbott

People needed

10777

Starts

2003-01-01

Expected to finish

2009-11-01

Last updated by the study team

2010-05-11

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Global Medical Services — North Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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