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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01228682
Recruitment Status : Unknown
Verified April 2013 by Otsuka Frankfurt Research Institute GmbH.
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2010
Last Update Posted : May 1, 2013
Information provided by (Responsible Party):
Otsuka Frankfurt Research Institute GmbH

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.

Condition or disease Intervention/treatment
SIADH Non-SIADH Hyponatremia Non-Hyponatremia Drug: Tolvaptan

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

  • 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 : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : October 2010
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan

Group/Cohort Intervention/treatment
Patients who are treated with Samsca. Drug: Tolvaptan
Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.
Other Name: Samsca

Primary Outcome Measures :
  1. Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age. [ Time Frame: 3 years ]
  2. Samsca sodium correction rates and adverse events in patients treated with Samsca [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are treated with Samsca

Inclusion Criteria:

  • Patients who are treated with Samsca

Exclusion Criteria:

  • Patients who have not signed the data consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01228682

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Sponsors and Collaborators
Otsuka Frankfurt Research Institute GmbH

Responsible Party: Otsuka Frankfurt Research Institute GmbH Identifier: NCT01228682     History of Changes
Other Study ID Numbers: 156-09-101
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013

Keywords provided by Otsuka Frankfurt Research Institute GmbH:

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs