NCT03364244

Revatio Special Investigation for Long-term Use in Pediatric Patients

Revatio Special Investigation - Investigation for Long-Term Use of Revatio in Pediatric Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,023 (actual)
• Sponsor: Viatris Pharmaceuticals Japan Inc · Industry
• Sex: All
• Age: 0 Years – 14 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Sildenafil	\[REVATIO® Tablets / REVATIO® OD Film\] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily. \[REVATIO® Dry Syrup for Suspension\] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 8 kg or more but less than 20 kg: Usually, sildenafil 10 mg is orally given three times daily. In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily.

Timeline

• Start date: 2017-11-30
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2017-12-06
• Last updated: 2022-10-03

Locations

1 site across 1 country: Japan