Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03364244
Previous Study | Return to List | Next Study

Revavtio Special Investigation for Long-term Use in Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03364244
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 30, 2017
First Posted Date December 6, 2017
Last Update Posted Date February 26, 2019
Actual Study Start Date November 30, 2017
Estimated Primary Completion Date March 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2017)
  • Incidence of adverse drug reactions [ Time Frame: 1 year (52 week) ofter start date ]
  • Effictiveness rate for physician's evaluation of this product [ Time Frame: 1 year (52 week) ofter start date ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 5, 2017)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Revavtio Special Investigation for Long-term Use in Pediatric Patients
Official Title REVATIO SPECIAL INVESTIGATION - INVESTIGATION FOR LONG-TERM USE OF REVATIO IN PEDIATRIC PATIENTS -
Brief Summary Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Pulmonary Arterial Hypertension
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.

Study Groups/Cohorts Sildenafil
Pediatric patients receiving Revatio
Intervention: Drug: Sildenafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 5, 2017)
190
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 28, 2022
Estimated Primary Completion Date March 28, 2022   (Final data collection date for primary outcome measure)
Eligibility 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:

  • None.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 14 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03364244
Other Study ID Numbers A1481319
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer 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. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2019