CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 125 enrolled
Drug / intervention
Ezetimibe +3 moredrug
Likely dose
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/NCT00871351
NCT00871351Phase 4Completed
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Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia

Organon and Co·interventional·Posted Mar 30, 2009·Updated May 23, 2024

In Brief

A Phase 4 clinical trial evaluating Ezetimibe, Atorvastatin, and 1 other intervention for Primary Hypercholesterolemia. Completed, enrolled 125 participants.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hypercholesterolemia
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.3 years ago

Interventions

Ezetimibedrug

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Atorvastatindrug

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Atorvastatindrug

2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)

Rosuvastatindrug

1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)