An observational study in Pulmonary Arterial Hypertension, sponsored by Viatris Pharmaceuticals Japan Inc. Completed at 1 site in Japan. Open to participants aged 0 Years to 14 Years. Per ClinicalTrials.gov, last updated 2022-10-03.
Sponsored by Viatris Pharmaceuticals Japan Inc · Observational
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) .
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:
Pediatric patients receiving Revatio
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.
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
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
Plan to share: No — Sponsor will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→