A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

Trial Profile

A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Oct 2017

At a glance

  • Drugs Canagliflozin (Primary)
  • Indications Cardiovascular disorders; Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms CANVAS
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 02 Oct 2017 According to a Janssen media release, the supplemental New Drug Application submitted by the company also applies to INVOKANA's fixed-dose combinations, INVOKAMET and INVOKAMET XR.
    • 02 Oct 2017 According to a Janssen media release, the company has submitted a supplemental New Drug Application to the U.S. Food & Drug Administration seeking a new indication for INVOKANA (canagliflozin) to reduce the risk of major adverse cardiovascular events, composed of cardiovascular death, myocardial infarction and stroke, in adults with type 2 diabetes who have established CV disease or are at risk for CV disease. The sNDA is based on data from CANVAS and CANVAS-R trials.
    • 17 Aug 2017 Results (n=10142) of integrated analysis of CANVAS and CANVAS-R trials published in the New England Journal of Medicine
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