A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)

This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.

Inclusion Criteria:

• Adult patients, >/=45 years of age
• Patients admitted to the hospital for acute coronary syndrome (ACS)
• Patients receiving guideline-based medical and dietary management of dyslipidemia

Exclusion Criteria:

• Symptomatic congestive heart failure (NYHA Class III or IV)
• Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
• Uncontrolled hypertension
• Uncontrolled diabetes
• Severe anemia
• Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)