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

Phase 3

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: dalcetrapib; Drug: placebo

• Registration Number: NCT01323153
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Disposition First Submitted: 2016-07-06
• Disposition First Submitted QC: 2016-07-06
• Disposition First Posted: 2016-07-11
• Results First Submitted: 2018-07-06
• Results First Submitted QC: 2018-07-06
• Results First Posted: 2018-08-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dalcetrapib	dalcetrapib	-
Placebo	placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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