A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Trial Profile

A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2017

At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Autosomal dominant polycystic kidney disease; Kidney disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms REPRISE
  • Sponsors Otsuka Pharmaceutical; Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 09 Nov 2017 According to an Otsuka Pharmaceutical media release, the U.S. Food and Drug Administration (FDA) has accepted the resubmission to support a regulatory review of New Drug Application (NDA) for tolvaptan in the treatment of adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The FDA considers the resubmission to be filed as of October 24, 2017, with a PDUFA action date of April 24, 2018.
    • 04 Nov 2017 Results published in the New England Journal of Medicine
    • 04 Nov 2017 Results presented in an Otsuka Pharmaceutical media release.
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