Status:
TERMINATED
A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass
Lead Sponsor:
Inotek Pharmaceuticals Corporation
Conditions:
Heart Diseases
Postoperative Complications
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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...
Detailed Description
Heart-lung bypass during heart surgery sometimes leads to side effects or complications after surgery. Studies have shown that PARP inhibitors protect cells from damage due to lack of oxygen. Heart-l...
Eligibility Criteria
Inclusion
- Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery
- Males and non-pregnant, non-lactating females
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00271167
Start Date
October 1 2005
End Date
June 1 2006
Last Update
March 25 2015
Active Locations (13)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73152
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Rapid City Regional Hospital
Rapid City, South Dakota, United States