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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
Sponsor:
Information provided by (Responsible Party):
Pfizer

November 30, 2017
December 6, 2017
February 8, 2018
November 30, 2017
March 28, 2022   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT03364244 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Revavtio Special Investigation for Long-term Use in Pediatric Patients
Revatio Special Investigation - Investigation For Long-term Use Of Revatio In Pediatric Patients -
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) .
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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
Pulmonary Arterial Hypertension
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.

Sildenafil
Pediatric patients receiving Revatio
Intervention: Drug: Sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
190
Same as current
March 28, 2022
March 28, 2022   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
up to 14 Years   (Child)
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Japan
 
 
NCT03364244
A1481319
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2018