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Revavtio Special Investigation for Long-term Use in Pediatric Patients

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Local Country Office
Tokyo, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-14
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT03364244
Pfizer
Recruiting
Revavtio Special Investigation for Long-term Use in Pediatric Patients

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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
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 [email protected]
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/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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