EUCTR2013-001268-44-Outside-EU/EEA进行中（未招募）1 期
Open label study to assess the efficacy, safety and dosing of clevidipine in pediatric patients undergoing surgery. - PIONEER
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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. Patient must be less than 18 years
- •2. Written informed consent obtained before initiation of any study-related procedures
- •3. The enrolling physician determines that patient will likely require a 15% reduction in BP during the perioperative course
- •4. Intra-arterial line available for blood pressure monitoring
- •5. Surgical procedure requiring at minimum 1 hour of anesthesia, in which IV antihypertensive therapy to control BP for at least 30 minutes is anticipated
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Administration of an IV or oral antihypertensive agent within 2 hours prior to study drug administration
- •2. Congenital heart disease described as single ventricle
- •3. Evidence of liver failure, severe liver disease, pulmonary disease (e.g. uncontrolled asthma), hyperlipidemia, lipoid nephrosis, lipid dysfunction or acute pancreatitis
- •4. Allergy to soya bean oil or egg lecithin
- •5. Known to be intolerant to calcium channel blockers
- •6. Hemophilia or blood coagulation disorders
- •7. Any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
- •8. Clinically significant abnormal physical findings at the screening evaluation
- •9. Any serious surgical or medical condition which, in the opinion of the investigator, is likely to interfere with study procedures or with the pharmacokinetics or pharmacodynamics of the study drug
- •10. Patient is terminally ill (death likely to occur within 48 hours)
- •11. Use of Methylphenidate, Calcium Channel blockers, Aripiprazole and other atypical anti psychotics and anti-hypertensives used for BP control within 2 hours prior to study drug initiation
- •12. Positive serum or urine pregnancy test for any female of childbearing potential
- •13. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
- •14. Patients who, for any reason, are deemed by the Investigator to be inappropriate for this study
- •15. Patient is a relative of the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff directly involved in the conduct of the study
- •16. Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
研究者
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