At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 135 enrolled
Drug / intervention
Ezetimibe +1 moredrug
Likely dose
Not stated in 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, Open-label, Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Patients With Hypercholesterolemia Who Have Inadequate LDL-C Control on Ezetimibe or Rosuvastatin Monotherapy
In Brief
A Phase 3 clinical trial evaluating Ezetimibe and Rosuvastatin for Hypercholesterolemia and Familial Hypercholesterolemia. Completed, enrolled 135 participants.
Detailed Summary
The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5 mg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartMay 2016
Primary CompletionDec 2017
TodayJul 2026
First PostedApr 22, 2016
Enrollment StartMay 18, 2016
Primary CompletionDec 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.2 years ago
Interventions
Ezetimibedrug
Rosuvastatindrug