Revatio Special Investigation for Long-term Use in Pediatric Patients

Viatris Pharmaceuticals Japan Inc1,023 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

1,023

Conditions

Pulmonary Arterial Hypertension

Interventions

SildenafilDRUG

\[REVATIO® Tablets / REVATIO® OD Film\] 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.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 14 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of adverse drug reactions

The number of cases of adverse drug reactions during the observation period and their ratio are tabulated for each SOC and PT.

Time frame: 1 year (52 week) after observation start date

Effictiveness rate for physician's evaluation of this product

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.

Time frame: 1 year (52 week) after observation start date

Secondary Outcomes

the dosage and administration under the actual use (including patients under the age of 1 year, weighing below 8 kg)

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.

Time frame: 1 year (52 week) after observation start date

Data from ClinicalTrials.gov

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