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
1 other identifier
observational
200
7 countries
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Typical duration for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 25, 2010
CompletedFirst Posted
Study publicly available on registry
October 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 1, 2013
April 1, 2013
3 years
October 25, 2010
April 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Patients who are treated with Samsca.
Interventions
Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.
Eligibility Criteria
Patients who are treated with Samsca
You may qualify if:
- Patients who are treated with Samsca
You may not qualify if:
- Patients who have not signed the data consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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 49.004
Cologne, Germany
Otsuka Study location 49.016
Dresden, Germany
Otsuka Study location 49.011
Düsseldorf, Germany
Otsuka Study location 49.002
Hamburg, Germany
Otsuka Study location 49.012
Hanover, Germany
Otsuka Study location 49.018
Hanover, Germany
Otsuka Study Location 49-020
Heidelberg, Germany
Otsuka Study location 49-024
Heidelberg, Germany
Otsuka Study location 49.009
Lübeck, 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
Würzburg, Germany
Otsuka Study location 39-001
Cuneo, Italy
Otsuka Study location 39.007
Florence, Italy
Otsuka Study location 39.005
Siena, Italy
Otsuka Study location 47-001
Lorenskog, Norway
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
Córdoba, Spain
Otsuka Study location 34-005
Madrid, Spain
Otsuka Study location 34.017
Majadahonda, Spain
Otsuka Study location 34-002
Seville, Spain
Otsuka Study location 34-012
Seville, Spain
Otsuka Study Location 46.001
Gothenburg, Sweden
Otsuka Study location 46-004
Karlstad, Sweden
Otsuka Study location 46.002
Linköping, Sweden
Otsuka Study location 46-003
Stockholm, Sweden
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, United Kingdom
Related Publications (1)
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.
PMID: 34693505DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2010
First Posted
October 26, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2013
Study Completion
April 1, 2014
Last Updated
May 1, 2013
Record last verified: 2013-04