Viewing Study NCT01312935


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Study NCT ID: NCT01312935
Status: TERMINATED
Last Update Posted: 2012-05-17
First Post: 2011-03-08
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Sponsor: PolyMedix, Inc.
Organization:

Study Overview

Official Title: A Phase 2 Proof of Concept Study of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Status: TERMINATED
Status Verified Date: 2012-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: PolyMedix decided to stop enrollment in both clinical trials due to observations of reductions in blood pressure.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Detailed Description: PMX-60056 is being developed as a rapid and effective reversal agent for use in those situations where anticoagulation by heparin, or LMWH must be quickly stopped. Potential uses include reversal of anticoagulation induced to prevent clotting during surgical procedures, and rescue from cases of inadvertent or unexpected overdose.

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?: