At a glance
ClinicalIndex Comparison Record- ✓BMI ≥27 and ≤45 kg/m² OR BMI ≥25 and <27 with waist circumference ≥102 cm (males) or ≥88 cm (females)
- ✓Preexisting cardiovascular disease (coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease) and/or type 2 diabetes mellitus with at least one additional risk factor (dyslipidemia, controlled hypertension, current smoking, or diabetic nephropathy with microalbuminuria)
- ✕History of recent myocardial infarction
- ✕Heart failure symptoms greater than NYHA Functional Class II
- ✕Hemodynamically significant valvular or left ventricular tract obstruction
- ✕Sinus bradycardia (<50 bpm), sick sinus syndrome, or atrioventricular block >1st degree (without pacemaker)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event
In Brief
A Phase 3 clinical trial evaluating Sibutramine hydrochloride and Placebo for Obesity. Completed, enrolled 10,777 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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