A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR
The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.
Inclusion Criteria:
≥50 years of age (women) or ≥45 years of age (men)
Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2
Waist circumference ≥88 cm (women) or ≥102 cm (men)
At increased risk of adverse cardiovascular outcomes:
Cardiovascular disease (confirmed diagnosis or at high likelihood of cardiovascular disease) with at least one of the following:
AND/OR
Type 2 diabetes mellitus with at least 2 of the following:
Exclusion Criteria:
Tuscson, Arizona, United States
Dearbon, Michigan, United States