NCT01228682

Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Otsuka Frankfurt Research Institute GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• SIADH
• Non-SIADH Hyponatremia
• Non-Hyponatremia

Interventions

Type	Name	Description
DRUG	Tolvaptan	Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-10-01
• Completion: 2014-04-01
• First posted: 2010-10-26
• Last updated: 2013-05-01

Locations

47 sites across 7 countries: Denmark, Germany, Italy, Norway, Spain, Sweden, United Kingdom