Status:
COMPLETED
Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
Brief Summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in thi...
Detailed Description
All the patients whom an investigator prescribes the first SILDENAFIL(Revatio) should be registered consecutively until the number of subjects reaches target number in order to extract patients enroll...
Eligibility Criteria
Inclusion
- Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.
Exclusion
- Patients not administered SILDENAFIL(Revatio).
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
3337 Patients enrolled
Trial Details
Trial ID
NCT00666198
Start Date
May 1 2008
End Date
June 1 2015
Last Update
February 1 2021
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