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A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease

Trial Profile

A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in 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 Adverse reactions; Pharmacokinetics
  • 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.
    • 18 Jan 2019 Status changed from active, no longer recruiting to completed.
    • 04 Dec 2018 This trial was completed in Czech Republic (end date: 2018-11-09), according to European Clinical Trials Database
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