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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: dalcetrapib
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dalcetrapib<br> | Drug: dalcetrapib<br>* Oral doses of 600 mg once daily for 20 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Oral doses of matching placebo to dalcetrapib once daily for 20 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Blood Lipid Levels |  | 20 weeks | 
| Percent Change From Baseline in Lipoprotein Levels |  | 20 weeks | 
| Percent Change From Baseline in Apolipoprotein Levels |  | 20 weeks | 
| Safety: Incidence of Adverse Events |  | 24 weeks |