Status:
COMPLETED
Revatio Special Investigation for Long-term Use in Pediatric Patients
Lead Sponsor:
Viatris Pharmaceuticals Japan Inc
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
Up to 14 years
Brief Summary
Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice
Detailed Description
The objective of this study is to obtain the information on dosage and administration, safety, and efficacy of Revatio when it is administered for a long period of time (1 year) under the actual use a...
Eligibility Criteria
Inclusion
- Pediatric patients aged 0 to under 15 years who were confirmed to have received Revatio after the approval date of dosage and administration of Revatio for pediatric patients.
Exclusion
- None.
Key Trial Info
Start Date :
November 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
1023 Patients enrolled
Trial Details
Trial ID
NCT03364244
Start Date
November 30 2017
End Date
August 30 2022
Last Update
October 3 2022
Active Locations (1)
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1
Viatris Pharmaceuticals Japan Inc., 5-11-2; Toranomon, Minato-ku
Tokyo, Japan