At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 321 enrolled
Drug / intervention
Ezetimibe 10 mg +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.
A Phase III, Randomized, Active Comparator-controlled, Clinical Trial to Study the Efficacy and Safety of MK-0653H in Japanese Patients With Hypercholesterolemia.
In Brief
A Phase 3 clinical trial evaluating Ezetimibe 10 mg, Rosuvastatin 2.5 mg, and 2 other interventions for Hypercholesterolemia. Completed, enrolled 321 participants.
Detailed Summary
This study will evaluate the efficacy and safety and tolerability of 2 dose levels of MK-0653H in Japanese participants. The primary hypotheses are that the administration of MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol (LDL-C) after 12 weeks of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionJan 2017
TodayJul 2026
First PostedApr 18, 2016
Enrollment StartJun 9, 2016
Primary CompletionJan 18, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.2 years ago
Interventions
Ezetimibe 10 mgdrug
Rosuvastatin 2.5 mgdrug
Placebo for Ezetimibedrug
Placebo for Rosuvastatindrug