Observation Study of the Medication Switch at Patients Treated With Sitaxentan to a Regime Without Sitaxentan
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Heidelberg.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Heidelberg
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01281371
First received: January 20, 2011
Last updated: November 4, 2011
Last verified: December 2010
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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 University of Heidelberg:
Biospecimen Retention: Samples With DNA
only remaining blood of the security laboratory for analysis of plasma concentrations of drugs
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281371
Contacts
| Contact: Walter E Haefeli, Prof. Dr. med. | 0049 622156 ext 8740 | walter.emil.haefeli@med.uni-heidelberg.de |
Locations
| Germany | |
| Department of Clinical Pharmacology and Pharmacoepidemiology, Medical department of the University of Heidelberg | Recruiting |
| Heidelberg, Baden-Württemberg, Germany, 69120 | |
| Contact: Walter E. Haefeli, Prof. Dr. med 0049 6221 56 ext 8740 walter.emil.haefeli@med.uni-heidelberg.de | |
Sponsors and Collaborators
University of Heidelberg
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: | November 4, 2011 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013