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

• Conditions: Non-Hyponatremia; SIADH; Non-SIADH Hyponatremia
• Interventions: Drug: Tolvaptan

• Registration Number: NCT01228682
• Lead Sponsor: Otsuka Frankfurt Research Institute GmbH

Brief 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-30
• Last Update Posted: 2013-05-01
• Primary Completion: 2013-10
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who are treated with Samsca

Exclusion Criteria

• Patients who have not signed the data consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who are treated with Samsca.	Tolvaptan	-

Primary Outcome Measures

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

Trial Locations

Locations (47)

Otsuka Study location 45-001; 🇩🇰 Copenhagen, Denmark

Otsuka Study location 45-006; 🇩🇰 Holstebro, Denmark

Otsuka Study location 49.007; 🇩🇪 Aachen, Germany

Otsuka Study location 49.016; 🇩🇪 Dresden, Germany

Otsuka Study location 49.011; 🇩🇪 Duesseldorf, Germany

Otsuka Study location 49.002; 🇩🇪 Hamburg, Germany

Otsuka Study location 49.012; 🇩🇪 Hannover, Germany

Otsuka Study location 49.018; 🇩🇪 Hannover, Germany

Otsuka Study Location 49-020; 🇩🇪 Heidelberg, Germany

Otsuka Study location 49-024; 🇩🇪 Heidelberg, Germany

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