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

NCT01228682 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2013-05-01

No results posted yet for this study

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.

Conditions

  • SIADH
  • Non-SIADH Hyponatremia
  • Non-Hyponatremia

Interventions

DRUG

Tolvaptan

Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.

Sponsors & Collaborators

  • Otsuka Frankfurt Research Institute GmbH

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-10-31
Completion
2014-04-30

Countries

  • Denmark
  • Germany
  • Italy
  • Norway
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01228682 on ClinicalTrials.gov