At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,425 enrolled
Drug / intervention
Apabetalone +3 moredrug
Likely dose
Apabetalone 100 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 Multi-Center, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Clinical Trial in High-Risk Type 2 Diabetes Mellitus (T2DM) Subjects With Coronary Artery Disease (CAD) to Determine Whether Bromodomain Extraterminal Domain (BET) Inhibition Treatment With RVX000222 Increases the Time to Major Adverse Cardiovascular Events (MACE)
In Brief
A Phase 3 clinical trial evaluating Apabetalone, Placebo, and 2 other interventions for Diabetes Mellitus, Type 2 and Coronary Artery Disease. Completed, enrolled 2,425 participants across 214 sites in 15 countries.
Detailed Summary
The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major adverse cardiovascular events.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Coronary Artery Disease
CountriesArgentina, Australia, Belgium, Bulgaria, Croatia, Germany, Hungary, Israel, Mexico, Netherlands, Poland, Russia, Serbia, Slovakia, Taiwan
CollaboratorsPPD Development, LP, ICON plc, Medidata Solutions
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartNov 2015
Primary CompletionNov 2020
Study CompletionJun 2021
TodayJul 2026
First PostedOct 26, 2015
Enrollment StartNov 1, 2015
Primary CompletionNov 30, 2020
Study CompletionJun 21, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.7 years ago
Interventions
Apabetalonedrug
100 mg capsule
Placebodrug
Capsule manufactured to mimic RVX000222 100 mg capsule
Atorvastatindrug
High-Intensity Statin
Rosuvastatindrug
High-Intensity Statin