Revavtio Special Investigation for Long-term Use in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT03364244|
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment|
|Pulmonary Arterial Hypertension||Drug: Sildenafil|
|Study Type :||Observational|
|Estimated Enrollment :||190 participants|
|Official Title:||Revatio Special Investigation - Investigation For Long-term Use Of Revatio In Pediatric Patients -|
|Actual Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||March 28, 2022|
|Estimated Study Completion Date :||March 28, 2022|
U.S. FDA Resources
Pediatric patients receiving Revatio
[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 [ Time Frame: 1 year (52 week) ofter start date ]
- Effictiveness rate for physician's evaluation of this product [ Time Frame: 1 year (52 week) ofter start date ]
- the dosage and administration under the actual use (including patients under the age of 1 year, weighing below 8 kg) [ Time Frame: 1 year (52 week) ofter start date ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364244
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Pfizer Local Country Office||Recruiting|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|