CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
dalcetrapib +1 moredrug
Likely dose
dalcetrapib 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01323153
NCT01323153Phase 3Completed
CompareCT.gov

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 Roche·interventional·Posted Mar 25, 2011·Updated Jul 30, 2019

In Brief

A Phase 3 clinical trial evaluating dalcetrapib and placebo for Coronary Heart Disease. Completed, enrolled 300 participants across 33 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Heart Disease
CountriesCzechia, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2011
Enrollment StartMar 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.3 years ago

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