At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 152 enrolled
Drug / intervention
Ezetimibe +1 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.
Examination of the Effect of Ezetimibe on Glucose Metabolism - Randomized, Double-blind, Placebo-controlled Study in Type 2 Diabetes Mellitus Patients With Hypercholesterolemia - Phase 4, Protocol No. 367 (Also Known as SCH 58235, P06541)
In Brief
A Phase 4 clinical trial evaluating Ezetimibe and Placebo for Hypercholesterolemia. Completed, enrolled 152 participants.
Detailed Summary
This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the placebo control group.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionJan 2014
TodayJul 2026
First PostedJun 5, 2012
Enrollment StartJul 2, 2012
Primary CompletionJan 16, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.1 years ago
Interventions
Ezetimibedrug
10 mg oral dose once daily for 24 weeks
Placebodrug
Placebo to match ezetimibe orally once daily for 24 weeks.