EUCTR2008-006968-11-DK进行中（未招募）不适用
Pharmacokinectics of AP214 Acetate in patients undergoing cardiac surgery.A randomized, double-blind, placebo-controlled sequential ascending dose trialinvestigating pharmacokinetics, as well as safety, tolerability and pharmacodynamics of three dosing regimens of AP214 administered intravenously
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Has signed the trial specific informed consent form.
- •2.Patients 18 to 80 years old, male or female, not of childbearing potential
- •(postmenopausal or permanently sterilized, e.g. tubal ligation,
- •hysterectomy, bilateral salpingectomy), regardless of ethnicity.
- •3.Patients undergoing CABG, valve(s), CABG/valve(s) and/or aortic root or
- •ascending aortic aneurysm repair surgery.
- •4.Cleveland Clinic Renal Score = 2 (higher than average risk for AKI).
- •5.EF = 30%, evaluated within 2 months prior to screening visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Cardiac surgery to be performed off pump” without cardiopulmonary
- •2.Circulatory arrest in connection with aortic root or ascending aortic
- •aneurysm repair surgery.
- •3.Confirmed or suspected endocarditis.
- •4.Requiring a reoperation on one of the valves within 3 months following the
- •original valve surgical procedure.
- •5.Receiving Aprotinin during the trial, from screening to Day 90.
- •6.Having undergone cardiovascular catherization = 48 hours prior to
- •scheduled surgery.
- •7.Active peptic ulcer disease and gastritis.
- •8.Hemoccult positive stools, hematological, bleeding, and coagulation
- •9.Receiving dopamine at renal doses (2-4 mcg/kg/min), from screening to
- •Day of surgery.
- •10.S-Creatinine greater than 2.1 mg/dl.
- •11.Known or suspected hypersensitivity to the investigational medicinal
- •12.Known or suspected hypersensitivity to ondansetron or other selective 5-
- •HT3 receptor antagonists
- •13.Current participation in any other interventional clinical trial.
- •14.Previously dosed with AP214.
- •15.Use of investigational medicinal products within the previous 6 months.
- •16.Body weight above 140 kg.
- •17.History of any organ transplant.
- •18.Women who are of childbearing potential, pregnant or breast-feeding.
- •19.Current abuse of alcohol or substance, according to the investigator’s
- •medical judgement.
- •20.Has a mental incapacity or language barriers precluding adequate
- •understanding of trial procedures.
- •21.Is considered by the Investigator unsuitable to participate in the trial for
- •any other reason, for instance due to a significant serious underlying
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