Revatio Special Investigation for Long-term Use in Pediatric Patients

Study Overview
=================
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) .

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

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sildenafil<br>Pediatric patients receiving Revatio | Drug: Sildenafil<br>* [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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Revatio, Pulmonary arterial hypertension, Pediatric patients