Ignite Creation Date:
2024-05-06 @ 12:42 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01642407
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2012-06-15
Brief Title:
Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
A Phase 3 Multi-center Open-label Study To Investigate Safety Efficacy And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary arterial hypertension PAH is a rare progressive and life-threatening disease In many patients the course of PAH is a steady deterioration and reduced life expectancy
Sildenafil was approved by the European Commission for the treatment of PAH in pediatric patients in May 2011 making it the first agent to be approved for the treatment of children with PAH The approval was based on the largest placebo-controlled study to be conducted in this population The recommended dose in pediatric patients aged 1 year to 17 years old is 10 mg TID in patients 20 kg and 20 mg TID for patients 20 kg Higher doses are not recommended in pediatrics patients
This study is an open-label multi-center study to investigate safety efficacy and pharmacokinetics of sildenafil citrate in Japanese pediatric patients with PAH
Sildenafil was approved by the European Commission for the treatment of PAH in pediatric patients in May 2011 making it the first agent to be approved for the treatment of children with PAH The approval was based on the largest placebo-controlled study to be conducted in this population The recommended dose in pediatric patients aged 1 year to 17 years old is 10 mg TID in patients 20 kg and 20 mg TID for patients 20 kg Higher doses are not recommended in pediatrics patients
This study is an open-label multi-center study to investigate safety efficacy and pharmacokinetics of sildenafil citrate in Japanese pediatric patients with PAH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None