Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery

PHASE2TerminatedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Cardiac SurgeryCoronary Artery Bypass GraftingValve SurgeryKidney Injury
Interventions
DRUG

AP214

Three AP214 bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).

DRUG

Placebo

Three placebo bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).

Trial Locations (2)

32601

Shands Hospital at Alachua General Hospital, Gainesville

32610

Shands Hopsital at University of Florida, Gainesville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Action Pharma A/S

INDUSTRY

NCT00628264 - Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery | Biotech Hunter | Biotech Hunter