This trial is active, not recruiting.

Conditions siadh, non-siadh hyponatremia, non-hyponatremia
Treatment tolvaptan
Sponsor Otsuka Frankfurt Research Institute GmbH
Start date October 2010
End date October 2013
Trial size 200 participants
Trial identifier NCT01228682, 156-09-101


A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice.

A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
tolvaptan Samsca
Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.

Primary Outcomes

Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age.
time frame: 3 years
Samsca sodium correction rates and adverse events in patients treated with Samsca
time frame: 3 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients who are treated with Samsca Exclusion Criteria: - Patients who have not signed the data consent form

Additional Information

Official title 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
Description Drug Utilisation Survey The drug utilisation analysis will describe the number of prescriptions, their distribution between different medical specialties, and indication for use as compared to the SmPC, patient age and patient gender distributions on a prescription level. In addition, the indication for use will be further categorised as - SIADH - Non-SIADH hyponatraemia - Non-Hyponatraemia Post-Authorisation Safety Study Sodium levels at baseline and rate of sodium correction under therapy will be analysed. Safety findings will be described. The number of all non-serious and serious adverse events and the relative frequencies will be analysed in consideration of the risk categories below: - Renal safety - Aquaresis-related adverse effects - Serum sodium correction rate - Glucose homeostasis - Cardiovascular safety and hemodynamics - Respiratory system - Drug metabolism and drug interactions - Drug exposure during pregnancy - Paediatric safety Subgroup analyses will be performed for all safety findings by indication subgroups (SIADH and other indications), subgroups according to SIADH-underlying diseases, age groups, hepatically impaired patients and renally impaired patients.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Otsuka Frankfurt Research Institute GmbH.