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

Otsuka Pharmaceutical Europe Ltd0 sites100 target enrollmentNovember 2015

ConditionsHyponatremia Syndrome of Inappropriate ADH (SIADH) Secretion

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hyponatremia
Sponsor: Otsuka Pharmaceutical Europe Ltd
Enrollment: 100
Primary Endpoint: Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

April 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Europe Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of patient informed consent unless a) not required by local regulations, b) it would take a non reasonable effort or c) if the source patient is deceased or untraceable.
•Female and/or male patients aged 18 years and over.
•Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH.

Exclusion Criteria

•A patient cannot take part in this study if participating in any other clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.

Outcomes

Primary Outcomes

Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge

Time Frame: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)

The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation).

Secondary Outcomes

Change in Sodium Levels 6 Weeks After Treatment Initiation(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)(Baseline)
Change in Sodium Levels 24 Hours After Treatment Initiation(From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards)
Time (Hours) to Sodium Normalisation(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)(Baseline)
Time (Days) to Sodium Normalisation(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)(Baseline)
Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia(Baseline)