CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 476 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
dalcetrapib 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/NCT00655538
NCT00655538Phase 2Completed
CompareCT.gov

A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

Hoffmann-La Roche·interventional·Posted Apr 10, 2008·Updated Jan 2, 2020

In Brief

A Phase 2 clinical trial evaluating Placebo and dalcetrapib for Coronary Heart Disease. Completed, enrolled 476 participants across 23 sites in 7 countries.

Detailed Summary

This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Heart Disease
CountriesAustria, France, Germany, Italy, Netherlands, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2008
Enrollment StartFeb 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.2 years ago

Interventions

Placebodrug

po daily for 36 weeks

dalcetrapibdrug

600mg po daily for 36 weeks