Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Otsuka Frankfurt Research Institute GmbH

ClinicalTrials.gov Identifier:

NCT01228682

First received: October 25, 2010

Last updated: April 30, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 25, 2010
Last Updated Date	April 30, 2013
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 25, 2010)	Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age. [ Time Frame: 3 years ] [ Designated as safety issue: No ] Samsca sodium correction rates and adverse events in patients treated with Samsca [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01228682 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients who are treated with Samsca
Condition ^ICMJE	SIADH Non-SIADH Hyponatremia Non-Hyponatremia
Intervention ^ICMJE	Drug: Tolvaptan Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician. Other Name: Samsca
Study Group/Cohort (s)	Patients who are treated with Samsca. Intervention: Drug: Tolvaptan
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	April 2014
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients who are treated with Samsca Exclusion Criteria: Patients who have not signed the data consent form
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark, Germany, Italy, Norway, Spain, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01228682
Other Study ID Numbers ^ICMJE	156-09-101
Has Data Monitoring Committee	No
Responsible Party	Otsuka Frankfurt Research Institute GmbH
Study Sponsor ^ICMJE	Otsuka Frankfurt Research Institute GmbH
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Otsuka Frankfurt Research Institute GmbH
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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