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Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD

NCT02586155 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2425

Last updated 2021-08-20

Study results available
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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.

Conditions

Interventions

DRUG

Apabetalone

100 mg capsule

DRUG

Placebo

Capsule manufactured to mimic RVX000222 100 mg capsule

DRUG

Atorvastatin

High-Intensity Statin

DRUG

Rosuvastatin

High-Intensity Statin

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • ICON plc

    collaborator INDUSTRY

  • Medidata Solutions

    collaborator INDUSTRY

  • Resverlogix Corp

    lead INDUSTRY

Principal Investigators

  • Kausik Ray, MD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-11-30
Completion
2021-06-21
FDA Drug
Yes

Countries

  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Croatia
  • Germany
  • Hungary
  • Israel
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02586155 on ClinicalTrials.gov