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A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Trial Profile

A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2019

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At a glance

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

    • 07 Jan 2019 Mexico was planned location as per European Clinical Trials Database.
    • 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.
    • 02 Aug 2018 According to an Otsuka Pharmaceutical media release, European Commission has approved an extension of indication for JINARC (tolvaptan) to include adult patients with CKD stage 4 Autosomal Dominant Polycystic Kidney Disease (ADPKD) on the basis of submission of data from this trial (REPRISE)
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