Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Trial Profile

Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2017

At a glance

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

    • 31 Mar 2017 Primary endpoint (Percent Change in Total Kidney Volume (TKV)) has not been met, according to results published in the Nephrology Dialysis Transplantation Journal.
    • 31 Mar 2017 Results published in the Nephrology Dialysis Transplantation Journal.
    • 04 May 2016 Status changed from active, no longer recruiting to completed.
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