Revatio 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

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1023

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Viatris Pharmaceuticals Japan Inc., 5-11-2; Toranomon, Minato-ku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

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

Collaborators and Investigators

• Sponsor: Viatris Pharmaceuticals Japan Inc
• Investigators: Study Director: Rajesh Nachankar, Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2017
• Primary Completion (ACTUAL): August 30, 2022
• Study Completion (ACTUAL): August 30, 2022

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (ACTUAL): December 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pulmonary arterial hypertension; Pediatric patients; Revatio
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: A1481319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sponsor will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No