Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-01 @ 7:24 AM
Study NCT ID:
NCT01585259
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2012-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anfibatide Phase Ib-IIa Clinical Trial
Sponsor:
Lee's Pharmaceutical Limited
Organization:
Study Overview
Official Title:
A Multi-center, Randomized, Double-blind, Multi-dose Group, Parallel Group and Placebo Controlled Phase Ib-IIa Clinical Study to Evaluate the Safety and Efficacy of Antiplatelet Thrombolysin for Injection for the Treatment of Patients With Non-ST Segment Elevation Myocardial Infarction (NSTEMI).
Status:
COMPLETED
Status Verified Date:
2015-07
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:
Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction patients
Detailed Description:
1. This study is a phase Ib-IIa exploratory study to observe the safety of Antiplatelet Thrombolysin for Injection for the treatment of non-ST segment myocardial infarction (NSTEMI) patients and preliminarily evaluate the efficacy of different doses, providing the theoretical basis of the phase II and III clinical study protocol.
2. To investigate the pharmacokinetics of different doses.
2. To investigate the pharmacokinetics of different doses.
Study Oversight
Has Oversight DMC:
True
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?: