Clinical trial NCT01228682: Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SIADH
Non-SIADH Hyponatremia
Non-Hyponatremia
Keywords: Sodium
SIADH
Hyponatremia
Vasopressin
Salt
Water
Lead sponsor: Otsuka Frankfurt Research Institute GmbH
Sponsor class: INDUSTRY
First posted: 2010-10-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are treated with Samsca

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.

Eligibility criteria: Inclusion Criteria:

* Patients who are treated with Samsca

Exclusion Criteria:

* Patients who have not signed the data consent form

Primary outcomes:
measure: Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age.
timeFrame: 3 years
measure: Samsca sodium correction rates and adverse events in patients treated with Samsca
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Otsuka Study location 45-001
city: Holstebro
country: Denmark
facility: Otsuka Study location 45-006
city: Aachen
country: Germany
facility: Otsuka Study location 49.007
city: Dresden
country: Germany
facility: Otsuka Study location 49.016
city: Duesseldorf
country: Germany
facility: Otsuka Study location 49.011
city: Hamburg
country: Germany
facility: Otsuka Study location 49.002
city: Hannover
country: Germany
facility: Otsuka Study location 49.012
city: Hannover
country: Germany
facility: Otsuka Study location 49.018
city: Heidelberg
country: Germany
facility: Otsuka Study Location 49-020
city: Heidelberg
country: Germany
facility: Otsuka Study location 49-024
city: Koeln
country: Germany
facility: Otsuka Study location 49.004
city: Luebeck
country: Germany
facility: Otsuka Study location 49.009
city: Mannheim
country: Germany
facility: Otsuka Study location 49.017
city: Regensberg
country: Germany
facility: Otsuka Study location 49-019
city: Rostock
country: Germany
facility: Otsuka Study location 49-021
city: Wuerzburg
country: Germany
facility: Otsuka study location 49-001
city: Cuneo
country: Italy
facility: Otsuka Study location 39-001
city: Florence
country: Italy
facility: Otsuka Study location 39.007
city: Siena
country: Italy
facility: Otsuka Study location 39.005
city: Lorenskog
country: Norway
facility: Otsuka Study location 47-001
city: Alicante
country: Spain
facility: Otsuka Study location 34-007
city: Castellon
country: Spain
facility: Otsuka Study location 34-014
city: Castellon
country: Spain
facility: Otsuka Study location 34-015
city: Cordoba
country: Spain
facility: Otsuka Study location 34-013
city: Madrid
country: Spain
facility: Otsuka Study location 34-005
city: Majadahonda
country: Spain
facility: Otsuka Study location 34.017
city: Sevilla
country: Spain
facility: Otsuka Study location 34-002
city: Sevilla
country: Spain
facility: Otsuka Study location 34-012
city: Goeteborg
country: Sweden
facility: Otsuka Study Location 46.001
city: Karlstad
country: Sweden
facility: Otsuka Study location 46-004
city: Linköping
country: Sweden
facility: Otsuka Study location 46.002
city: Stockholm
country: Sweden
facility: Otsuka Study location 46-003
city: Birmingham
country: United Kingdom
facility: Otsuka Study location 44.024
city: Coventry
country: United Kingdom
facility: Otsuka Study location 44.019
city: Durham
country: United Kingdom
facility: Otsuka Study location 44.003
city: Hartlepool
country: United Kingdom
facility: Otsuka Study location 44-023
city: Kingston
country: United Kingdom
facility: Otsuka Study location 44.005
city: Liverpool
country: United Kingdom
facility: Otsuka Study location 44.006
city: Liverpool
country: United Kingdom
facility: Otsuka Study location 44.016
city: Manchester
country: United Kingdom
facility: Otsuka Study location 44-001
city: Manchester
country: United Kingdom
facility: Otsuka Study location 44.007
city: Manchester
country: United Kingdom
facility: Otsuka Study location 44.013
city: Nuneaton
country: United Kingdom
facility: Otsuka Study location 44.021
city: Oldham
country: United Kingdom
facility: Otsuka Study location 44-027
city: Oldham
country: United Kingdom
facility: Otsuka Study location 44.015
city: Preston
country: United Kingdom
facility: Otsuka Study location 44-025
city: Southampton
country: United Kingdom
facility: Otsuka Study location 44.004
Study officials:
References:
citation: Estilo A, McCormick L, Rahman M. Using Tolvaptan to Treat Hyponatremia: Results from a Post-authorization Pharmacovigilance Study. Adv Ther. 2021 Dec;38(12):5721-5736. doi: 10.1007/s12325-021-01947-9. Epub 2021 Oct 25.