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)

Trial Profile

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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2017

At a glance

  • Drugs Apabetalone (Primary) ; Atorvastatin; Rosuvastatin
  • Indications Cardiovascular disorders; Coronary artery disease
  • Focus Registrational; Therapeutic Use
  • Acronyms BETONMACE
  • Sponsors Resverlogix Corporation
  • Most Recent Events

    • 01 Nov 2017 According to a Resverlogix Corporation media release, full enrollment is now anticipated in the first half of 2018.
    • 01 Nov 2017 To date, this trial has over 1,950 patients enrolled, representing approximately over 80 percent of total planned enrollment, according to a Resverlogix Corporation media release.
    • 01 Nov 2017 According to a Resverlogix Corporation media release, the independent Data and Safety Monitoring Board (DSMB) has completed a fifth planned safety review and recommended that the study should continue as planned without any modifications. DSMB reviewed available study data and noted that no safety or efficacy concerns were identified, and will conduct additional periodic reviews.
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