Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
NCT ID: NCT01228682
Last Updated: 2013-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2010-10-31
2014-04-30
Brief Summary
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A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients who are treated with Samsca.
Tolvaptan
Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.
Interventions
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Tolvaptan
Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Otsuka Frankfurt Research Institute GmbH
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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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.
Other Identifiers
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156-09-101
Identifier Type: -
Identifier Source: org_study_id
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