Pulmonary Arterial Hypertension
Conditions
Keywords
Revatio, Pulmonary arterial hypertension, Pediatric patients
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) .
Interventions
DRUGSildenafil
\[REVATIO® Tablets / REVATIO® OD Film\] 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
Viatris Pharmaceuticals Japan Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Outcome results
None listed