Clinical Trials Logo
  1. Home
  2. Pulmonary Arterial Hypertension
  3. NCT03364244
  4. Details
NCT03364244 Clinical Trial

Revatio Special Investigation for Long-term Use in Pediatric Patients

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03364244
Other study ID # A1481319
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2017
Est. completion date August 30, 2022

Study information
Verified date September 2022
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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) .

Recruitment information / eligibility
Status Completed
Enrollment 1023
Est. completion date August 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 0 Years to 14 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Japan Viatris Pharmaceuticals Japan Inc., 5-11-2; Toranomon, Minato-ku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Viatris Pharmaceuticals Japan Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
See also
  Status Clinical Trial Phase
Completed NCT04076241 - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension N/A
Completed NCT05521113 - Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Recruiting NCT04972656 - Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension N/A
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Active, not recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Recruiting NCT04266197 - Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study Phase 2
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Terminated NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00942708 - Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension Phase 2
Completed NCT00902174 - Imatinib (QTI571) in Pulmonary Arterial Hypertension Phase 3

External Links