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

October 25, 2010
April 30, 2013
October 2010
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01228682 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients who are treated with Samsca

  • SIADH
  • Non-SIADH Hyponatremia
  • Non-Hyponatremia
Drug: Tolvaptan
Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.
Other Name: Samsca
Patients who are treated with Samsca.
Intervention: Drug: Tolvaptan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
April 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are treated with Samsca

Exclusion Criteria:

  • Patients who have not signed the data consent form
Both
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No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   Italy,   Norway,   Spain,   Sweden,   United Kingdom
 
NCT01228682
156-09-101
No
Otsuka Frankfurt Research Institute GmbH
Otsuka Frankfurt Research Institute GmbH
Not Provided
Not Provided
Otsuka Frankfurt Research Institute GmbH
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP