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Completed

NCT Number: NCT03364244

Revatio Special Investigation for Long-term Use in Pediatric Patients

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

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

0 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Tokyo, Japan

About this study

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) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of adverse drug reactions

    Time frame: 1 year (52 week) after observation start date

    The number of cases of adverse drug reactions during the observation period and their ratio are tabulated for each SOC and PT.

  2. Effictiveness rate for physician's evaluation of this product

    Time frame: 1 year (52 week) after observation start date

    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.

Secondary outcomes

  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) after observation start date

    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.

Sponsors and collaborators

Lead sponsor

Viatris Pharmaceuticals Japan Inc

Industry

Registry information

Official study title

Revatio Special Investigation - Investigation for Long-Term Use of Revatio in Pediatric Patients

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2017
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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