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A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan Followed by a Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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Trial Profile

A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan Followed by a Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2024

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At a glance

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

    • 04 Apr 2024 Results estimating risk of rapid disease progression in pediatric patients with autosomal dominant polycystic kidney disease published in the Pediatric Nephrology
    • 01 Jan 2023 Primary endpoint (Coprimary end points (Change from baseline in spot urine osmolality and specific gravity at week 1, assessed inhibition of antidiuretic hormone activity)) has been met, as per results published in the Clinical Journal of The American Society of Nephrology: CJASN.
    • 01 Jan 2023 Results assessing the safety and efficacy of tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease, published in the Clinical Journal of The American Society of Nephrology: CJASN.
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