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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 : January 10, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: Sildenafil

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) .

Study Design

Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Case-Only
Time Perspective: Prospective
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


Groups and Cohorts

Group/Cohort Intervention/treatment
Sildenafil
Pediatric patients receiving Revatio
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.



Outcome Measures

Primary Outcome Measures :
  1. Incidence of adverse drug reactions [ Time Frame: 1 year (52 week) ofter start date ]
  2. Effictiveness rate for physician's evaluation of this product [ Time Frame: 1 year (52 week) ofter start date ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
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:

Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Japan
Pfizer Local Country Office Recruiting
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03364244     History of Changes
Other Study ID Numbers: A1481319
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Revatio
Pulmonary arterial hypertension
Pediatric patients

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents