A Study of INO-1001, an Intravenous PARP (Poly [ADP Ribose] Polymerase) Inhibitor in Acute Heart Attack Patients Undergoing Primary Percutaneous Coronary Intervention

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the safety of INO-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inotek Pharmaceuticals Corporation

Criteria

Inclusion Criteria:

• Subjects with acute myocardial infarction (as defined in protocol) with onset within 24 hours prior to randomization.

• Scheduled for primary percutaneous coronary intervention within 3 hours of presentation at a hospital participating in this study.

• Males and non-pregnant, non-lactating females.

Exclusion Criteria:

• Subjects will be required to undergo a full medical review in order to exclude serious medical, or psychological illness prior to inclusion.

• History of a hypersensitivity reaction to more than three drugs or mannitol.

• Participation in any investigational study within 30 days of randomization

• Treatment with certain restricted medications within a specified time prior to participation in the study.