TerminatedPhase 2

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

Stopped: It was determined that the study was not appropriate for demonstrating therapeutic benefit in the cardiopulmonary bypass patient population.

United States162 participantsStarted 2005-10

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Reduction in serious post-operative complications occurring in the first thirty days after surgery.

Trial details

NCT IDNCT00271167

SponsorInotek Pharmaceuticals Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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