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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2019

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At a glance

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

    • 07 Jan 2019 Results of population pharmacokinetic analyses and model validation of Tolvaptan from 5 phase II trials (NCT00413777, NCT01210560, NCT01214421 and NCT02160145) published in the Journal of Clinical Pharmacology.
    • 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.
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