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NCT03364244 Clinical Trial

Revatio Special Investigation for Long-term Use in Pediatric Patients

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03364244
Other study ID # A1481319
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2017
Est. completion date August 30, 2022

Study information
Verified date September 2022
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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) .

Recruitment information / eligibility
Status Completed
Enrollment 1023
Est. completion date August 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 0 Years to 14 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Japan Viatris Pharmaceuticals Japan Inc., 5-11-2; Toranomon, Minato-ku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Viatris Pharmaceuticals Japan Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 year (52 week) after observation start date
Primary 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. 1 year (52 week) after observation start date
Secondary 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. 1 year (52 week) after observation start date
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