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: 03 Aug 2017

At a glance

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

    • 22 May 2017 Status changed from active, no longer recruiting to completed, according to an Otsuka Pharmaceutical media release.
    • 22 May 2017 According to an Otsuka Pharmaceutical media release, the trial results are intended to address the Complete Response Letter (CRL) issued by the FDA for a New Drug Application (NDA) for tolvaptan in ADPKD in 2013.
    • 22 May 2017 According to an Otsuka Pharmaceutical media release, results from the trial will be submitted for presentation at a nephrology medical congress in the second half of 2017.
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