At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 135 enrolled
Drug / intervention
EZ 10 mg/Atorva 20 mg FDC +1 moredrug
Likely dose
EZ 10 mg/Atorva 20 mg FDCfrom 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.
A Phase III, Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Patients With Hypercholesterolemia Who Have Inadequate LDL-C Control on Ezetimibe or Atorvastatin Calcium Monotherapy
In Brief
A Phase 3 clinical trial evaluating EZ 10 mg/Atorva 20 mg FDC and EZ 10 mg/Atorva 10 mg FDC for Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia. Completed, enrolled 135 participants.
Detailed Summary
This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJun 2015
Primary CompletionDec 2016
TodayJul 2026
First PostedJun 2, 2015
Enrollment StartJun 23, 2015
Primary CompletionDec 22, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.1 years ago
Interventions
EZ 10 mg/Atorva 20 mg FDCdrug
EZ 10 mg/Atorva 10 mg FDCdrug