Ignite Creation Date:
2024-05-06 @ 3:31 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02304198
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2014-11-26
Brief Title:
Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH
Sponsor:
Dong-A ST Co Ltd
Organization:
Dong-A ST Co Ltd
Study Overview
Official Title:
A Single-arm Open-label Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial HypertensionPAH
Status:
COMPLETED
Status Verified Date:
2016-04
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:
This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial HypertensionPAH All the patients will receive Udenafil for 1-year48-weeks
Detailed Description:
Pulmonary arterial Hypertension is characterized by a progressive incerease in pulmonary vascular resistancePVR leading to right ventricualar failure
Udenafil inhibits PDE 5 an enzyme that metabolizes cGMP enhancing the cGMP mediated relaxation and growth inhibition of vascular smooth muscle cells including those in the lung
Udenafil inhibits PDE 5 an enzyme that metabolizes cGMP enhancing the cGMP mediated relaxation and growth inhibition of vascular smooth muscle cells including those in the lung
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