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 CV risk in patients hospitalized for an acute coronary syndrome (ACS) when treatment is initiated within 1 week after an ACS (dal-ACUTE). - dal-ACUTE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022529-14-CZ

Enrollment

300

Registered

2010-12-23

Start date

2011-02-04

Completion date

Unknown

Last updated

2014-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease MedDRA version: 14.0 Level: LLT Classification code 10068617 Term: Coronary heart disease System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Dalcetrapib Product Code: RO4607381 Pharmaceutical Form: Tablet INN or Proposed INN: Dalcetrapib CAS Number: 211513-37-0 Current Sponsor code: RO4607381 Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients, >/=45 years of age - Patients admitted to the hospital for acute coronary syndrome (ACS), defined as the occurence of: spontaneous myocardial infarction; hospitalization for ACS (Electrocardiogram abnormalities without biomarkers elevation) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Women who are pregnant or breastfeeding - Women of childbearing potential who are not using a highly effective contraceptive method at randomization - Patients who have symptomatic congestive heart failure ([CHF], New York Heart Association [NYHA] Class III or IV) - Clinically significant heart disease which is anticipated to require coronary artery bypass grafting (CBAG), cardiac transplantation, surgical repair and/or replacement of valves during the double-blind treatment phase of the study

Design outcomes

Primary

Measure	Time frame
Main Objective: -To evaluate the effect of dalcetrapib on high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment when treatment is initiated within one week after an ACS. ;Secondary Objective: -Similarity in percent change from baseline in high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment in studies WC25501 and NC20971. - Percent change of high-density lipoprotein C (HDL-C) treatment levels after 8, 12 and 20 weeks of treatment - Percent change from baseline in blood lipid levels - Percent change from baseline in Lipoprotein levels - Percent change from baseline in Apolipoprotein levels - Incidence of adverse events, timeframe: 24 weeks ;Primary end point(s): Primary efficacy endpoint: Percent change from baseline in HDL-C levels after 4 weeks of treatment.	—

Measure

Time frame

Main Objective: -To evaluate the effect of dalcetrapib on high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment when treatment is initiated within one week after an ACS. ;Secondary Objective: -Similarity in percent change from baseline in high-density lipoprotein C (HDL-C) levels after 4 weeks of treatment in studies WC25501 and NC20971. - Percent change of high-density lipoprotein C (HDL-C) treatment levels after 8, 12 and 20 weeks of treatment - Percent change from baseline in blood lipid levels - Percent change from baseline in Lipoprotein levels - Percent change from baseline in Apolipoprotein levels - Incidence of adverse events, timeframe: 24 weeks ;Primary end point(s): Primary efficacy endpoint: Percent change from baseline in HDL-C levels after 4 weeks of treatment.

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Countries

Czech Republic, Netherlands, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026