A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass

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

Summary

The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP ribose] polymerase) inhibitor, in patients undergoing heart surgery. The study also measures whether INO-1001 reduces the side effects caused by heart-lung bypass machines.

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

Details

• Lead Sponsor: Inotek Pharmaceuticals Corporation

Criteria

Inclusion Criteria:

• Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery

• 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 to mannitol

• Participation in any other investigational study within 30 days of the screening phase

• Known alcohol or drug abuse within the last year

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