Revatio Special Investigation for Long-term Use in Pediatric Patients

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Sildenafil

• Registration Number: NCT03364244
• Lead Sponsor: Viatris Pharmaceuticals Japan Inc

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

Study Timeline

• Study Start: 2017-11-30
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-06
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1023

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

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil	Pediatric patients receiving Revatio

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions	1 year (52 week) after observation start date	The number of cases of adverse drug reactions during the observation period and their ratio are tabulated for each SOC and PT.
Effictiveness rate for physician's evaluation of this product	1 year (52 week) after observation start date	For the judgment of clinical effect at each evaluation time point (16th week, 52nd week and final evaluation time), the frequency (number of cases) and the ratio of each classification (valid, invalid, undecidable) are calculated.

Secondary Outcome Measures

Name	Time	Method
the dosage and administration under the actual use (including patients under the age of 1 year, weighing below 8 kg)	1 year (52 week) after observation start date	The mean doses at the initial , 16th, 52nd, and final evaluations are summarized for each newly treated case since dosage approval and continued case before dosage approval.

Trial Locations

Locations (1)

Viatris Pharmaceuticals Japan Inc., 5-11-2; Toranomon, Minato-ku; 🇯🇵 Tokyo, Japan