Clinical Trial: An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Non Interventional, Retrospective Study on Real World Usage and Treatment Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to the SIADH.

Brief Summary: This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.

Detailed Summary:
Sponsor: Otsuka Pharmaceutical Europe Ltd

Current Primary Outcome: Change in sodium levels from start of treatment with tolvaptan until hospital discharge [ Time Frame: Up to discharge (or a maximum of 6 weeks after start of treatment) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in sodium levels 24 hours after 24 hours from treatment initiation [ Time Frame: 24 hours after treatment initiation ]
  • Change in sodium levels 6 weeks after treatment initiation [ Time Frame: 6 weeks after treatment initiation ]
  • Time (hours) to sodium normalisation [ Time Frame: Longitudinal (up to 6 weeks after treatment initiation) ]
  • Distribution (%) of the primary disease diagnoses leading to SIADH (cancer, pulmonary disease, CNS disorder, etc.) [ Time Frame: Baseline ]
  • Symptoms associated with hyponatraemia (number of symptomatic/asymptomatic patients and % of presence of the different symptoms in the study population) [ Time Frame: Baseline ]
  • Distribution (%) of the specialties of the clinicians prescribing tolvaptan endocrinologists, nephrologists, oncologists, etc.). [ Time Frame: Baseline ]
  • Average dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia being captured in the study [ Time Frame: Treatment duration (up to 6 weeks after treatment initiation) ]


Original Secondary Outcome:

  • Change in sodium levels 24 hours after 24 hours from treatment initiation [ Time Frame: 24 hours after treatment initiation ]
  • Change in sodium levels 6 weeks after treatment initiation [ Time Frame: 6 weeks after treatment initiation ]
  • Time (hours) to sodium normalisation [ Time Frame: Longitudinal (up to 6 weeks after treatment initiation) ]
  • Primary disease diagnoses leading to SIADH [ Time Frame: Baseline ]
  • Symptoms associated with hyponatraemia [ Time Frame: Baseline ]
  • Specialty of the clinician prescribing tolvaptan [ Time Frame: Baseline ]
  • Average dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia being captured in the study [ Time Frame: Treatment duration (up to 6 weeks after treatment initiation) ]


Information By: Otsuka Pharmaceutical Europe Ltd

Dates:
Date Received: September 7, 2015
Date Started: November 2015
Date Completion:
Last Updated: April 15, 2016
Last Verified: April 2016