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

Stopped early · Phase 2

Conditions studied: Heart Diseases, Postoperative Complications

In brief

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.

Key facts

Study ID

NCT00271167

Run by

Inotek Pharmaceuticals Corporation

People needed

162

Starts

2005-10-01

Expected to finish

2006-06-01

Last updated by the study team

2015-03-25

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery
• Males and non-pregnant, non-lactating females

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Rapid City Regional Hospital — Rapid City, South Dakota, United States
• Methodist Hospital — Houston, Texas, United States
• Study site — Sydney, New South Wales, Australia
• Ashford Cardiac Clinic / Adelaide Cardiac — Adelaide, South Australia, Australia
• St. Vincent's Hospital — Melbourne, Victoria, Australia
• Royal Perth Hospital — Perth, Western Australia, Australia
• Care Hospital — Hyderabad, India
• Escorts Heart Institute and Research Centre — New Delhi, India
• Wolfson Medical Centre — Holon, Israel
• Study site — Jerusalem, Israel

Full record on ClinicalTrials.gov

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