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
  Purpose

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 Intervention
SIADH
Non-SIADH Hyponatremia
Non-Hyponatremia
Drug: Tolvaptan

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Otsuka Frankfurt Research Institute GmbH:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are treated with Samsca

Criteria

Inclusion Criteria:

  • Patients who are treated with Samsca

Exclusion Criteria:

  • Patients who have not signed the data consent form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228682

  Show 47 Study Locations
Sponsors and Collaborators
Otsuka Frankfurt Research Institute GmbH
  More Information

No publications provided

Responsible Party: Otsuka Frankfurt Research Institute GmbH
ClinicalTrials.gov Identifier: NCT01228682     History of Changes
Other Study ID Numbers: 156-09-101
Study First Received: October 25, 2010
Last Updated: April 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Otsuka Frankfurt Research Institute GmbH:
Sodium
SIADH
Hyponatremia
Vasopressin
Salt
Water

Additional relevant MeSH terms:
Hyponatremia
Inappropriate ADH Syndrome
Water-Electrolyte Imbalance
Metabolic Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014