Status:
TERMINATED
Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery
Lead Sponsor:
Action Pharma A/S
Conditions:
Cardiac Surgery
Coronary Artery Bypass Grafting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft an...
Eligibility Criteria
Inclusion
- Has signed the trial specific informed consent form.
- Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
- Patients undergoing CABG, valve(s), CABG/valve and/or aortic root or ascending aortic aneurysm repair surgery.
- Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
- EF ≥ 30%, evaluated within 2 months prior to screening visit.
Exclusion
- Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
- Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
- Confirmed or suspected endocarditis.
- Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
- Receiving Aprotinin during the trial, from Screening to Day 90.
- Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
- Active peptic ulcer disease and gastritis.
- Hemoccult positive stools, hematological, bleeding, and coagulation disorders.
- Receiving dopamine at renal doses (2-4 mcg/kg/min), from Screening to Day 90.
- S-Creatinine greater than 2.1 mg/dl.
- Known or suspected hypersensitivity to the investigational medicinal product.
- Known or suspected hypersensitivity to ondansetron or other selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists.
- Current participation in any other interventional clinical trial.
- Previously dosed with AP214.
- Use of investigational medicinal products within the previous 6 months.
- Body weight above 140 kg.
- History of any organ transplant.
- Women who are of childbearing potential, pregnant or breast-feeding.
- Current abuse of alcohol or substance, according to the investigator's medical judgment
- Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
- Is considered by the Investigator unsuitable to participate in the trial for any other reason for instance due to a significant serious underlying condition
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00628264
Start Date
March 1 2008
End Date
June 1 2009
Last Update
June 1 2009
Active Locations (2)
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1
Shands Hospital at Alachua General Hospital
Gainesville, Florida, United States, 32601
2
Shands Hopsital at University of Florida
Gainesville, Florida, United States, 32610