Revatio Special Investigation for Long-term Use in Pediatric Patients

NCT03364244 | Completed

• 1 other identifier: A1481319
• Study Type: observational
• Target: 1,023
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Arterial Hypertension

Keywords

Revatio; Pulmonary arterial hypertension; Pediatric patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• the dosage and administration under the actual use (including patients under the age of 1 year, weighing below 8 kg)

  1 year (52 week) after observation start date

Study Arms (1)

Sildenafil

Pediatric patients receiving Revatio

Drug: Sildenafil

Interventions

Sildenafil DRUG

\[REVATIO® Tablets / REVATIO® OD Film\] 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

Eligibility Criteria

• Age: 0 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Viatris Pharmaceuticals Japan Inc: lead

Study Sites (1)

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

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rajesh Nachankar

  Viatris Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: November 30, 2017
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)