Ignite Creation Date:
2024-05-05 @ 9:56 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00993408
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2009-10-09
Brief Title:
Study of ACT-293987 NS-304 in Pulmonary Arterial Hypertension PAH
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multi-centre Multinational Open-label Single-dose Acute Hemodynamic Study Followed by Multi-centre Multinational Randomized Double-blind Parallel-group Placebo Controlled Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Efficacy Proof-of-concept of ACT-293987 NS-304 in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over
Status:
COMPLETED
Status Verified Date:
2023-08
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 is a multi-centre multinational open-label single-dose acute hemodynamic study followed by randomized double-blind parallel-group placebo controlled study Eligible subjects will undergo an open-label single-dose acute hemodynamic study with ACT-293987NS-304 and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 NS-304 or placebo bid Subjects who have completed the double-blind study can enter the open extension study separate protocol and receive administration of ACT-293987 NS-304 if the subject wishes and the Investigator considers it appropriate
Detailed Description:
This is a multi-centre multinational open-label single-dose acute hemodynamic study followed by a randomized double-blind parallel-group placebo controlled study Eligible subjects will undergo screening followed by randomized allocation to treatment group for the double-blind study followed in turn by immediate enrollment in an open-label single-dose acute hemodynamic study with ACT-293987 NS-304 and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 NS-304or placebo twice daily bid Subjects who have completed the double-blind study can enter the open extension study and receive administration of ACT-293987 NS-304 separate protocolif the subject wishes and the investigator considers it appropriate
Unblinding will occur on a subject-by-subject basis when the Week 17 data for the subject have been fixed
Approximately 44 subjects are to be randomized in a ratio of 31 to the two treatment groups ACT-293987 NS-304 and placebo 33 subjects to ACT-293987 NS-304 and 11 subjects to placebo
Subjects will be randomized to the study following screening
Unblinding will occur on a subject-by-subject basis when the Week 17 data for the subject have been fixed
Approximately 44 subjects are to be randomized in a ratio of 31 to the two treatment groups ACT-293987 NS-304 and placebo 33 subjects to ACT-293987 NS-304 and 11 subjects to placebo
Subjects will be randomized to the study following screening
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