Status:
UNKNOWN
Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
Lead Sponsor:
Otsuka Frankfurt Research Institute GmbH
Conditions:
SIADH
Non-SIADH Hyponatremia
Eligibility:
All Genders
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 informati...
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 SmP...
Eligibility Criteria
Inclusion
- Patients who are treated with Samsca
Exclusion
- Patients who have not signed the data consent form
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01228682
Start Date
October 1 2010
End Date
April 1 2014
Last Update
May 1 2013
Active Locations (47)
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1
Otsuka Study location 45-001
Copenhagen, Denmark
2
Otsuka Study location 45-006
Holstebro, Denmark
3
Otsuka Study location 49.007
Aachen, Germany
4
Otsuka Study location 49.004
Cologne, Germany