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A Phase 1b, Multicenter, Pilot, Randomized, Double-blind Trial to Determine the Pharmacokinetics and Pharmacodynamics of Orally Administered Tolvaptan 3.75, 7.5, and 15 mg Tablets in Subjects With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Trial Profile

A Phase 1b, Multicenter, Pilot, Randomized, Double-blind Trial to Determine the Pharmacokinetics and Pharmacodynamics of Orally Administered Tolvaptan 3.75, 7.5, and 15 mg Tablets in Subjects With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 Aug 2017

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At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Hyponatraemia; Inappropriate antidiuretic hormone secretion
  • Focus Pharmacodynamics
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 12 Aug 2017 Results of this and other study comparing low dose tolvaptan in patients with hyponatremia with healthy adults, published in the European Journal of Clinical Pharmacology.
    • 22 Jun 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 07 Jan 2015 Planned End Date changed from 1 Dec 2014 to 1 May 2015 according to ClinicalTrials.gov record.
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