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

April 30, 2013 updated by: Otsuka Frankfurt Research Institute GmbH

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Otsuka Study location 45-001
      • Holstebro, Denmark
        • Otsuka Study location 45-006
  • Germany
      • Aachen, Germany
        • Otsuka Study location 49.007
      • Dresden, Germany
        • Otsuka Study location 49.016
      • Duesseldorf, Germany
        • Otsuka Study location 49.011
      • Hamburg, Germany
        • Otsuka Study location 49.002
      • Hannover, Germany
        • Otsuka Study location 49.012
      • Hannover, Germany
        • Otsuka Study location 49.018
      • Heidelberg, Germany
        • Otsuka Study Location 49-020
      • Heidelberg, Germany
        • Otsuka Study location 49-024
      • Koeln, Germany
        • Otsuka Study location 49.004
      • Luebeck, Germany
        • Otsuka Study location 49.009
      • Mannheim, Germany
        • Otsuka Study location 49.017
      • Regensberg, Germany
        • Otsuka Study location 49-019
      • Rostock, Germany
        • Otsuka Study location 49-021
      • Wuerzburg, Germany
        • Otsuka study location 49-001
  • Italy
      • Cuneo, Italy
        • Otsuka Study location 39-001
      • Florence, Italy
        • Otsuka Study location 39.007
      • Siena, Italy
        • Otsuka Study location 39.005
  • Norway
      • Lorenskog, Norway
        • Otsuka Study location 47-001
  • Spain
      • Alicante, Spain
        • Otsuka Study location 34-007
      • Castellon, Spain
        • Otsuka Study location 34-014
      • Castellon, Spain
        • Otsuka Study location 34-015
      • Cordoba, Spain
        • Otsuka Study location 34-013
      • Madrid, Spain
        • Otsuka Study location 34-005
      • Majadahonda, Spain
        • Otsuka Study location 34.017
      • Sevilla, Spain
        • Otsuka Study location 34-002
      • Sevilla, Spain
        • Otsuka Study location 34-012
  • Sweden
      • Goeteborg, Sweden
        • Otsuka Study Location 46.001
      • Karlstad, Sweden
        • Otsuka Study location 46-004
      • Linköping, Sweden
        • Otsuka Study location 46.002
      • Stockholm, Sweden
        • Otsuka Study location 46-003
  • United Kingdom
      • Birmingham, United Kingdom
        • Otsuka Study location 44.024
      • Coventry, United Kingdom
        • Otsuka Study location 44.019
      • Durham, United Kingdom
        • Otsuka Study location 44.003
      • Hartlepool, United Kingdom
        • Otsuka Study location 44-023
      • Kingston, United Kingdom
        • Otsuka Study location 44.005
      • Liverpool, United Kingdom
        • Otsuka Study location 44.006
      • Liverpool, United Kingdom
        • Otsuka Study location 44.016
      • Manchester, United Kingdom
        • Otsuka Study location 44-001
      • Manchester, United Kingdom
        • Otsuka Study location 44.007
      • Manchester, United Kingdom
        • Otsuka Study location 44.013
      • Nuneaton, United Kingdom
        • Otsuka Study location 44.021
      • Oldham, United Kingdom
        • Otsuka Study location 44-027
      • Oldham, United Kingdom
        • Otsuka Study location 44.015
      • Preston, United Kingdom
        • Otsuka Study location 44-025
      • Southampton, United Kingdom
        • Otsuka Study location 44.004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are treated with Samsca

Description

Inclusion Criteria:

  • Patients who are treated with Samsca

Exclusion Criteria:

  • Patients who have not signed the data consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • Samsca

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Frankfurt Research Institute GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 26, 2010

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156-09-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on SIADH

Clinical Trials on Tolvaptan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe