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

Hoffmann-La Roche300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Coronary Heart Disease

Interventions

dalcetrapibDRUG

Oral doses of 600 mg once daily for 20 weeks

placeboDRUG

Oral doses of matching placebo to dalcetrapib once daily for 20 weeks

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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)

Locations (33)

Unnamed facility

Pensacola, Florida, United States

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

Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971

Time frame: 4 weeks

Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment

Time frame: 20 weeks

Percent Change From Baseline in Blood Lipid Levels

Time frame: 20 weeks

Percent Change From Baseline in Lipoprotein Levels

Time frame: 20 weeks

Percent Change From Baseline in Apolipoprotein Levels

Time frame: 20 weeks

Safety: Incidence of Adverse Events

Time frame: 24 weeks

Data from ClinicalTrials.gov

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