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
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: January 20, 2011
Last Updated: June 26, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014