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.
1 other identifier
observational
9
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 27, 2013
December 1, 2010
2.4 years
January 20, 2011
June 26, 2013
Conditions
Eligibility Criteria
Patients treated with Sitaxentan
You may qualify if:
- Pulmonary hypertension
- Treatment with Sitaxentan
You may not qualify if:
- Inability or unwillingness to give written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Pharmacology and Pharmacoepidemiology, Medical department of the University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Biospecimen
only remaining blood of the security laboratory for analysis of plasma concentrations of drugs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walter E. Haefeli, Prof. Dr. med.
Department of Clinical Pharmacology and Pharmacoepidemiology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 21, 2011
Study Start
January 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 27, 2013
Record last verified: 2010-12