Revatio Special Investigation for Long-term Use in Pediatric Patients

Viatris

Status

Completed

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: Sildenafil

Study type

Observational

Funder types

Industry

Identifiers

NCT03364244

A1481319

Details and patient eligibility

About

Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice

Full 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 after the approval of the dosage and administration in pediatric patients (aged 1 year or older, weighed 8 kg or more) .

Enrollment

1,023 patients

Sex

All

Ages

Under 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria