Extrait

-To demonstrate that, in obese and overweight subjects with cardiovascular (CV) disease and/or multiple CV risk factors, lorcaserin HCl 10 mg administered twice daily (BID) does not increase the incidence of major adverse cardiovascular events (MACE = myocardial infarction [MI], or stroke, or CV death) compared to placebo, with a noninferiority margin for the hazard ratio of 1.4 -To confirm that, in subjects with prediabetes at Baseline based on 2013ADA guideline, lorcaserin HCl 10 mg BID reduces the incidence of conversion to type 2 diabetes mellitus (T2DM) compared to placebo -To demonstrate that, in obese and overweight subjects with CV disease and/or multiple CV risk factors, lorcaserin HCl 10 mg BID reduces the incidence of MACE+ (MACE or hospitalization for unstable angina or heart failure (HF), or any coronary revascularization) compared to placebo

Critère d'inclusion

• Obese and overweight patients with cardiovascular (CV) disease and/or multiple CV risk factors

Liens

• ictrp
• euctr