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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Dalcetrapib

Criteria

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)