Ignite Creation Date:
2024-05-06 @ 1:25 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01808313
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2013-02-28
Brief Title:
Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension PAH
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2017-05
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 open label single-arm non-controlled multicentre study will determine the effect of ambrisentan on exercise capacity 6MWT in Chinese subjects with PAH The study consists of a screening period of 4 weeks a 12-week primary evaluation period PEP and a 12-week dose-adjustment period DAP Ambrisentan 5 mg will be administered to eligible subjects for 12 weeks PEP
Detailed Description:
Pulmonary arterial hypertension PAH consists of a group of progressive and incurable diseases of the pulmonary vasculature These are characterised by profound vasoconstriction and abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries which leads to a progressive increase in pulmonary vascular resistance PVR and sustained elevations in pulmonary artery pressure PAP A variety of drug classes have been used to treat PAH but no single compound has yet been shown to be effective in treating all patients with the disease Three widely used treatment options are calcium channel blockers CCBs diuretics and anticoagulants but all have varying responsesThere is a lack of clinical data on ambrisentan among the Chinese populationAmbrisentan is conditionally approved for the treatment of PAH in ChinaA clinical trial with a minimum of 100 patients in the ambrisentan arm was requested by SFDASeveral PAH medications have been approved in China so a placebo-controlled study is not ethically appropriate while an active control non-inferiority design is unfeasible due to sample size requirements and inconsistency in indications
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