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

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2017

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

    • 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
    • 17 Dec 2015 Results of post-hoc analysis published in the Nephrology Dialysis Transplantation
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