Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT00984802
Status:
COMPLETED
Last Update Posted:
2011-06-20
First Post:
2009-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy
Sponsor:
Ischemix, LLC
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase 2a Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1)
Status:
COMPLETED
Status Verified Date:
2011-06
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:
SUPPORT-1
Brief Summary:
This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: