A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients
Condition: Obesity
MeSH terms: Obesity; Overweight
Intervention: Sibutramine hydrochloride; Placebo; Sibutramine hydrochloride
Intervention description: One 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.); 1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.); 10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management
Intervention MeSH terms: Sibutramine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10777.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Obesity; Sibutramine

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.
    

Eligibility 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.