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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

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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: 14 Mar 2023

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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

  • 01 Mar 2023 Results assessing the clinical pattern and hepatic safety profile of tolvaptan in patients with autosomal dominant polycystic kidney disease from NCT00428948 (TEMPO 3:4), NCT01214421 (TEMPO 4:4), NCT02160145 (REPRISE), and NCT02251275 (long-term extension) studies, published in the American Journal of Kidney Diseases.
  • 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

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