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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Inotek Pharmaceuticals Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00271167
First received: December 29, 2005
Last updated: December 11, 2006
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Heart Diseases
Postoperative Complications
Drug: INO-1001
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Tolerability, Safety, Pharmacokinetics and Efficacy of Intravenous INO-1001 in High Risk Subjects Undergoing Cardiopulmonary Bypass for Coronary Revascularization and/or Valve Surgery.

Resource links provided by NLM:


Further study details as provided by Inotek Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Reduction in serious post-operative complications occurring in the first thirty days after surgery.

Estimated Enrollment: 162
Study Start Date: October 2005
Estimated Study Completion Date: June 2006
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-lung bypass during heart surgery can result in cells being deprived of oxygen. INO-1001 may be able to protect these cells and reduce complications following surgery.

A total of 162 patients will be randomly assigned to either INO-1001 or placebo (sugar water). Treatment will begin on the day of heart surgery and continue for 36 hours. A total of 4 doses of INO-1001 will be given. Patients will be followed up until 30 days after surgery.

The following information will be collected: symptoms, vital signs, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts.

The information provided in this listing is disclosed solely to comply with regulatory requirements. The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271167

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Oklahoma
University of Oklahoma
Oklahoma, Oklahoma, United States, 73152
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
Australia, New South Wales
Sydney, New South Wales, Australia
Australia, South Australia
Ashford Cardiac Clinic / Adelaide Cardiac
Adelaide, South Australia, Australia
Australia, Victoria
St. Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
India
Care Hospital
Hyderabad, India
Escorts Heart Institute and Research Centre
New Delhi, India, 110029
Israel
Wolfson Medical Centre
Holon, Israel, 58100
Jerusalem, Israel
Sponsors and Collaborators
Inotek Pharmaceuticals Corporation
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00271167     History of Changes
Other Study ID Numbers: IPC-05-2004
Study First Received: December 29, 2005
Last Updated: December 11, 2006
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Israel: Ministry of Health
India: Ministry of Health

Keywords provided by Inotek Pharmaceuticals Corporation:
Cardiac surgery
PARP inhibitor
PARP inhibition
Bypass surgery
CPB surgery
Cardiopulmonary bypass
Coronary revascularization
Cardiac valve replacement

Additional relevant MeSH terms:
Heart Diseases
Postoperative Complications
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014