Status:
TERMINATED
A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin
Lead Sponsor:
Pfizer
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Brief Summary
The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU) that is designed to supplement the reporting of spontaneous adverse events (AE) and better characterize known ...
Detailed Description
Non-probability sample
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document by the patient indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion.
- Additional inclusion criteria reflect the approved label for Thelin as outlined in the SmPC.
Exclusion
- There are no specific exclusion criteria for enrollment in the Thelin Patient Safety Registry, with the exception of those reflected in the approved label for Thelin as outlined in the SmPC.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00995566
Start Date
April 1 2010
End Date
February 1 2011
Last Update
February 7 2012
Active Locations (4)
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1
Pfizer Investigational Site
Brussels, Belgium, 1070
2
Pfizer Investigational Site
Leuven, Belgium, 3000
3
Pfizer Investigational Site
Nice, France, 06000
4
Pfizer Investigational Site
Hanover, Germany, 30625