Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05437224
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2022-06-24
Brief Title:
Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
A Multicenter Open Label Study to Evaluate Efficacy and Safety of China Made Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2022-06
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:
AMBLE
Brief Summary:
This multicenter open label single-arm study is aim at investigating the the efficacy and safety of china made ambrisentan in Chinese subjects with PAH
Detailed Description:
Pulmonary arterial hypertension is a hemodynamic and pathophysiological state which can cause progressive hyperplasia of pulmonary vascular walls and elevated pulmonary arterial pressure for various reasons Ambrisentan is a selective endothelin-A ETA receptor antagonist with vasodilatory antiproliferative and vascular remodeling effects at a dose of 5 mg or 10 mg once daily oral A number of international clinical studies have shown that ambrisentan can improve the hemodynamic parameters WHO functional classification and exercise tolerance of PAH patients and improve the survival rate The domestic Ambrisentan tablet is produced by Jiangsu Hansoh Pharmaceutical Group Co Ltd under the trade name of Pu Nuo An It has been developed and completed according to the consistency evaluation standard after the bioequivalence test and is currently listed in mainland China In view of the low price of the domestic ambrisentan in order to verify its efficacy and safety in the real world this post-marketing multicenter clinical study was carried out
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None