CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 440 enrolled
Drug / intervention
Comparator: rosuvastatin 5 mg + ezetimibe 10 mg +3 moredrug
Likely dose
Comparator: rosuvastatin 5 mg + ezetimibe 10 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/NCT00783263
NCT00783263Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease

Organon and Co·interventional·Posted Oct 31, 2008·Updated May 14, 2024

In Brief

A Phase 3 clinical trial evaluating Comparator: rosuvastatin 5 mg + ezetimibe 10 mg, Comparator: rosuvastatin 10 mg, and 2 other interventions for Hypercholesterolemia. Completed, enrolled 440 participants.

Detailed Summary

A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2008
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.7 years ago

Interventions

Comparator: rosuvastatin 5 mg + ezetimibe 10 mgdrug

Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.

Comparator: rosuvastatin 10 mgdrug

Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.

Comparator: rosuvastatin 10 mg + ezetimibe 10 mgdrug

Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.

Comparator: rosuvastatin 20 mgdrug

Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.