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This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).

Trial Profile

This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).

Completed
Phase of Trial: Phase II

Latest Information Update: 07 Jan 2019

At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Adverse reactions
  • Acronyms TEMPO 2/4
  • 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.
    • 27 Feb 2017 New trial record
    • 20 Feb 2017 Results of three phase II studies published in the Journal of Clinical Pharmacology
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