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Revatio Special Investigation for Long-term Use in Pediatric Patients

NCT03364244 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1023

Last updated 2022-10-03

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Viatris Pharmaceuticals Japan Inc

    lead INDUSTRY

Principal Investigators

  • Rajesh Nachankar · Viatris Inc.

Eligibility

Min Age
0 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2022-08-30
Completion
2022-08-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03364244 on ClinicalTrials.gov