Observation Study of the Medication Switch at Patients Treated With Sitaxentan to a Regime Without Sitaxentan

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01281371
First received: January 20, 2011
Last updated: June 26, 2013
Last verified: December 2010

January 20, 2011
June 26, 2013
January 2011
June 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01281371 on ClinicalTrials.gov Archive Site
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Observation Study of the Medication Switch at Patients Treated With Sitaxentan to a Regime Without Sitaxentan
Clinical Devolution of a Medication Change at Patients With Mono- or Combination Therapy With Sitaxentan to a Regime Without Sitaxentan.

Due to the withdrawal of Thelin (Sitaxentan) in December 2010 all patients with pulmonary hypertension treated with Sitaxentan need to be switched to an alternative therapy. This study will observe in which way the change of medication - in the clinical routine, without exception in charge of the treating physician - affects clinical and laboratory parameters and patient's quality of life.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

only remaining blood of the security laboratory for analysis of plasma concentrations of drugs

Non-Probability Sample

Patients treated with Sitaxentan

Hypertension, Pulmonary
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pulmonary hypertension
  • Treatment with Sitaxentan

Exclusion Criteria:

  • Inability or unwillingness to give written informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01281371
K344
No
Prof. Dr. med. Walter E. Haefeli, Department of Clinical Pharmacology and Pharmacoepidemiology
Heidelberg University
Not Provided
Principal Investigator: Walter E. Haefeli, Prof. Dr. med. Department of Clinical Pharmacology and Pharmacoepidemiology
Heidelberg University
December 2010

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