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)
Phase of Trial: Phase III
Latest Information Update: 04 Oct 2017
At a glance
- Drugs Apabetalone (Primary) ; Atorvastatin; Rosuvastatin
- Indications Cardiovascular disorders; Low HDL cholesterol
- Focus Registrational; Therapeutic Use
- Acronyms BETONMACE
- Sponsors Resverlogix Corporation
- 29 Aug 2017 To date, this trial has over 1,750 patients enrolled, representing approximately 75 percent of total planned enrollment, according to a Resverlogix Corporation media release.
- 25 Jul 2017 To date, the trial has enrolled over 70 percent of the planned 2400 patients, according to a Resverlogix Corporation media release.
- 25 Jul 2017 According to a Resverlogix Corporation media release, the company has received a positive Type C written response from the Division of Metabolism and Endocrinology Products of the U.S. FDA and allowed the Company to include USA patients in Phase 3 studies, including the BETonMACE trial. Subsequently, the company has agreed to make adjustments to the existing BETonMACE study protocol and to update the Investigator's Brochure and the Informed Consent Documents.