CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
dalcetrapib (RO4607381) +1 moredrug
Likely dose
dalcetrapib (RO4607381) 900mgfrom 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/NCT00400439
NCT00400439Phase 2Completed
CompareCT.gov

A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381

Hoffmann-La Roche·interventional·Posted Nov 16, 2006·Updated Jan 3, 2020

In Brief

A Phase 2 clinical trial evaluating dalcetrapib (RO4607381) and placebo for Coronary Heart Disease. Completed, enrolled 77 participants across 9 sites.

Detailed Summary

This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Heart Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 16, 2006
Enrollment StartJan 1, 2007
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.6 years ago

Interventions

dalcetrapib (RO4607381)drug

900mg po daily for 24 weeks

placebodrug

po daily for 24 weeks