CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 292 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
Pravastatin 40mgfrom 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/NCT00697203
NCT00697203Phase 2Completed
CompareCT.gov

A Randomized, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels

Hoffmann-La Roche·interventional·Posted Jun 13, 2008·Updated Jan 2, 2020

In Brief

A Phase 2 clinical trial evaluating Placebo, Pravastatin, and 1 other intervention for Dyslipidemia. Completed, enrolled 292 participants across 33 sites.

Detailed Summary

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 13, 2008
Enrollment StartJul 1, 2005
Primary CompletionMay 1, 2006
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.1 years ago

Interventions

Placebodrug

po daily for 12 weeks

Pravastatindrug

40mg po daily for 12 weeks

Dalcetrapibdrug

300mg po daily for 12 weeks

Dalcetrapibdrug

600mg po daily for 12 weeks

Dalcetrapibdrug

900mg po daily for 12 weeks