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A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease

Trial Profile

A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2019

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At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Registrational; Therapeutic Use
  • Acronyms TEMPO3:4
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 24 Apr 2018 According to an Otsuka Pharmaceutical media release, the US FDA has approved tolvaptan (JYNARQUE) as the first drug treatment to slow kidney function decline in adults at risk rapidly progressing autosomal dominant polycystic kidney diesase (ADPKD). The regulatory application included data from this trial.
    • 01 May 2017 Results of determinants of urine osmolality published in the Journal of the American Society of Nephrology
    • 15 Apr 2016 Results of a post-hoc analysis published in the Nephrology Dialysis Transplantation
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