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A Multi-Centre, Multi-National, Observational Post-Authorisation Safety Study to Document the Drug Utilisation of Samsca and to Collect Information on the Safety of Samsca When Used in Routine Medical Practice

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Trial Profile

A Multi-Centre, Multi-National, Observational Post-Authorisation Safety Study to Document the Drug Utilisation of Samsca and to Collect Information on the Safety of Samsca When Used in Routine Medical Practice

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 01 Nov 2021

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At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Hyponatraemia
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 25 Oct 2021 Status changed from active, no longer recruiting to completed as per results published in the Advances in Therapy
  • 25 Oct 2021 The definition of rapid correction of hyponatremia as used originally in the study was changed to align with the criteria used in the tolvaptan SmPC ,the definition of rapid correction of hyponatremia was extended from 48 to 72 h to include patients who were tested for serum sodium after 48 h after response to a query from the European Medicines Agency on the clinical study report as per results published in the Advances in Therapy
  • 25 Oct 2021 Results published in the Advances in Therapy

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