Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
- Conditions
- Non-HyponatremiaSIADHNon-SIADH Hyponatremia
- Interventions
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Patients who are treated with Samsca
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Otsuka Study location 39-001
๐ฎ๐นCuneo, Italy
Otsuka Study location 39.007
๐ฎ๐นFlorence, Italy
Otsuka Study location 39.005
๐ฎ๐นSiena, Italy
Otsuka Study location 49.007
๐ฉ๐ชAachen, Germany
Otsuka Study location 45-001
๐ฉ๐ฐCopenhagen, Denmark
Otsuka Study location 47-001
๐ณ๐ดLorenskog, Norway
Otsuka Study location 34-013
๐ช๐ธCordoba, Spain
Otsuka Study location 34-005
๐ช๐ธMadrid, Spain
Otsuka Study location 34.017
๐ช๐ธMajadahonda, Spain
Otsuka Study location 34-014
๐ช๐ธCastellon, Spain
Otsuka Study location 34-015
๐ช๐ธCastellon, Spain
Otsuka Study location 49-021
๐ฉ๐ชRostock, Germany
Otsuka Study location 49-019
๐ฉ๐ชRegensberg, Germany
Otsuka study location 49-001
๐ฉ๐ชWuerzburg, Germany
Otsuka Study location 34-012
๐ช๐ธSevilla, Spain
Otsuka Study location 34-007
๐ช๐ธAlicante, Spain
Otsuka Study location 34-002
๐ช๐ธSevilla, Spain
Otsuka Study Location 46.001
๐ธ๐ชGoeteborg, Sweden
Otsuka Study location 44.019
๐ฌ๐งCoventry, United Kingdom
Otsuka Study location 44.024
๐ฌ๐งBirmingham, United Kingdom
Otsuka Study location 44.003
๐ฌ๐งDurham, United Kingdom
Otsuka Study location 44-023
๐ฌ๐งHartlepool, United Kingdom
Otsuka Study location 44.006
๐ฌ๐งLiverpool, United Kingdom
Otsuka Study location 44.016
๐ฌ๐งLiverpool, United Kingdom
Otsuka Study location 44-001
๐ฌ๐งManchester, United Kingdom
Otsuka Study location 44.015
๐ฌ๐งOldham, United Kingdom
Otsuka Study location 46-004
๐ธ๐ชKarlstad, Sweden
Otsuka Study location 46.002
๐ธ๐ชLinkรถping, Sweden
Otsuka Study location 46-003
๐ธ๐ชStockholm, Sweden
Otsuka Study location 44.005
๐ฌ๐งKingston, United Kingdom
Otsuka Study location 44.021
๐ฌ๐งNuneaton, United Kingdom
Otsuka Study location 44.007
๐ฌ๐งManchester, United Kingdom
Otsuka Study location 44.013
๐ฌ๐งManchester, United Kingdom
Otsuka Study location 44-027
๐ฌ๐งOldham, United Kingdom
Otsuka Study location 44-025
๐ฌ๐งPreston, United Kingdom
Otsuka Study location 44.004
๐ฌ๐งSouthampton, United Kingdom
Otsuka Study location 45-006
๐ฉ๐ฐHolstebro, Denmark
Otsuka Study location 49.016
๐ฉ๐ชDresden, Germany
Otsuka Study location 49.002
๐ฉ๐ชHamburg, Germany
Otsuka Study location 49.011
๐ฉ๐ชDuesseldorf, Germany
Otsuka Study location 49.018
๐ฉ๐ชHannover, Germany
Otsuka Study Location 49-020
๐ฉ๐ชHeidelberg, Germany
Otsuka Study location 49.012
๐ฉ๐ชHannover, Germany
Otsuka Study location 49.004
๐ฉ๐ชKoeln, Germany
Otsuka Study location 49-024
๐ฉ๐ชHeidelberg, Germany
Otsuka Study location 49.009
๐ฉ๐ชLuebeck, Germany
Otsuka Study location 49.017
๐ฉ๐ชMannheim, Germany