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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01281371
First Posted: January 21, 2011
Last Update Posted: June 27, 2013
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.
Information provided by:
Heidelberg University
  Purpose
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.

Condition
Hypertension, Pulmonary

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Devolution of a Medication Change at Patients With Mono- or Combination Therapy With Sitaxentan to a Regime Without Sitaxentan.

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Biospecimen Retention:   Samples With DNA
only remaining blood of the security laboratory for analysis of plasma concentrations of drugs

Enrollment: 9
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with Sitaxentan
Criteria

Inclusion Criteria:

  • Pulmonary hypertension
  • Treatment with Sitaxentan

Exclusion Criteria:

  • Inability or unwillingness to give written informed consent
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01281371


Locations
Germany
Department of Clinical Pharmacology and Pharmacoepidemiology, Medical department of the University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Walter E. Haefeli, Prof. Dr. med. Department of Clinical Pharmacology and Pharmacoepidemiology
  More Information

Responsible Party: Prof. Dr. med. Walter E. Haefeli, Department of Clinical Pharmacology and Pharmacoepidemiology
ClinicalTrials.gov Identifier: NCT01281371     History of Changes
Other Study ID Numbers: K344
First Submitted: January 20, 2011
First Posted: January 21, 2011
Last Update Posted: June 27, 2013
Last Verified: December 2010

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sitaxsentan
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action