Ignite Creation Date:
2024-05-05 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00554619
Status:
COMPLETED
Last Update Posted:
2012-11-04
First Post:
2007-11-05
Brief Title:
A Study to Evaluate GSK1325760A - a Long-Term Extension Study
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study AMB107818 Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension PAH- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study -
Status:
COMPLETED
Status Verified Date:
2012-10
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:
The primary objective of this study is to evaluate the safety of long-term administration of GSK1325760A in patients with PAH
The secondary objectives of this study are to evaluate long-term administration of GSK1325760A on
Improvement in exercise capacity six-minutes walk distance 6MWD change in WHO Functional Classification and time to clinical worsening of PAH
Change in the Borg Dyspnea Index assessed immediately following the six-minute walk test 6MWT
Change in plasma brain natriuretic peptide BNP levels
Cardiopulmonary hemodynamics parameters as measured by echocardiography
The secondary objectives of this study are to evaluate long-term administration of GSK1325760A on
Improvement in exercise capacity six-minutes walk distance 6MWD change in WHO Functional Classification and time to clinical worsening of PAH
Change in the Borg Dyspnea Index assessed immediately following the six-minute walk test 6MWT
Change in plasma brain natriuretic peptide BNP levels
Cardiopulmonary hemodynamics parameters as measured by echocardiography
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