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

SIADH Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01228682
• Other study ID #: 156-09-101
• Status: Active, not recruiting
• Phase: N/A
• First received: October 25, 2010
• Last updated: April 30, 2013
• Start date: October 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2013
• Source: Otsuka Frankfurt Research Institute GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who are treated with Samsca

Exclusion Criteria:

• Patients who have not signed the data consent form

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyponatremia
• Non-Hyponatremia
• Non-SIADH Hyponatremia
• SIADH

Intervention

Drug:
• Tolvaptan
Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.

Locations

Country	Name	City	State
Denmark	Otsuka Study location 45-001	Copenhagen
Denmark	Otsuka Study location 45-006	Holstebro
Germany	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	Otsuka Study location 49.004	Koeln
Germany	Otsuka Study location 49.009	Luebeck
Germany	Otsuka Study location 49.017	Mannheim
Germany	Otsuka Study location 49-019	Regensberg
Germany	Otsuka Study location 49-021	Rostock
Germany	Otsuka study location 49-001	Wuerzburg
Italy	Otsuka Study location 39-001	Cuneo
Italy	Otsuka Study location 39.007	Florence
Italy	Otsuka Study location 39.005	Siena
Norway	Otsuka Study location 47-001	Lorenskog
Spain	Otsuka Study location 34-007	Alicante
Spain	Otsuka Study location 34-014	Castellon
Spain	Otsuka Study location 34-015	Castellon
Spain	Otsuka Study location 34-013	Cordoba
Spain	Otsuka Study location 34-005	Madrid
Spain	Otsuka Study location 34.017	Majadahonda
Spain	Otsuka Study location 34-002	Sevilla
Spain	Otsuka Study location 34-012	Sevilla
Sweden	Otsuka Study Location 46.001	Goeteborg
Sweden	Otsuka Study location 46-004	Karlstad
Sweden	Otsuka Study location 46.002	Linköping
Sweden	Otsuka Study location 46-003	Stockholm
United Kingdom	Otsuka Study location 44.024	Birmingham
United Kingdom	Otsuka Study location 44.019	Coventry
United Kingdom	Otsuka Study location 44.003	Durham
United Kingdom	Otsuka Study location 44-023	Hartlepool
United Kingdom	Otsuka Study location 44.005	Kingston
United Kingdom	Otsuka Study location 44.006	Liverpool
United Kingdom	Otsuka Study location 44.016	Liverpool
United Kingdom	Otsuka Study location 44-001	Manchester
United Kingdom	Otsuka Study location 44.007	Manchester
United Kingdom	Otsuka Study location 44.013	Manchester
United Kingdom	Otsuka Study location 44.021	Nuneaton
United Kingdom	Otsuka Study location 44-027	Oldham
United Kingdom	Otsuka Study location 44.015	Oldham
United Kingdom	Otsuka Study location 44-025	Preston
United Kingdom	Otsuka Study location 44.004	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Frankfurt Research Institute GmbH

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age.		3 years	No
Primary	Samsca sodium correction rates and adverse events in patients treated with Samsca		3 years	Yes