CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Dalcetrapib (RO4607381) +1 moredrug
Likely dose
Dalcetrapib (RO4607381) 600mgfrom 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/NCT00655473
NCT00655473Phase 2Completed
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A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors

Hoffmann-La Roche·interventional·Posted Apr 10, 2008·Updated Jan 3, 2020

In Brief

A Phase 2 clinical trial evaluating Dalcetrapib (RO4607381) and Placebo for Coronary Heart Disease. Completed, enrolled 130 participants across 12 sites in 2 countries.

Detailed Summary

This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Heart Disease
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2008
Enrollment StartMar 1, 2008
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.2 years ago

Interventions

Dalcetrapib (RO4607381)drug

600mg po daily for 24 months

Placebodrug

po daily for 24 months