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)

Hoffmann-La Roche0 sites300 target enrollmentMarch 2011

ConditionsCoronary Heart Disease

Interventionsplacebo dalcetrapib

Drugsdalcetrapib placebo

Overview

Phase: Phase 3
Intervention: placebo
Conditions: Coronary Heart Disease
Sponsor: Hoffmann-La Roche
Enrollment: 300
Primary Endpoint: Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

March 2012

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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)

Arms & Interventions

Placebo

Intervention: placebo

Dalcetrapib

Intervention: dalcetrapib

Outcomes

Primary Outcomes

Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment

Time Frame: 4 weeks

Secondary Outcomes

Safety: Incidence of Adverse Events(24 weeks)
Percent Change From Baseline in Lipoprotein Levels(20 weeks)
Percent Change From Baseline in Blood Lipid Levels(20 weeks)
Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971(4 weeks)
Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment(20 weeks)
Percent Change From Baseline in Apolipoprotein Levels(20 weeks)