NCT00984802已完成2 期
A Prospective, Randomized, Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase 2a Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 5
- 主要终点
- Safety as measured by changes in CK-MB
研究概览
简要总结
This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have stable coronary artery disease undergoing elective PCI.
- •Female subjects not of child-bearing potential.
- •Absence of ST segment depression >1.0 mm and absence of ST elevation >1.0 mm in any lead on the baseline 12-lead ECG.
- •subjects with CK-MB and troponin-T levels lower than the upper limit of normal.
- •Subjects free of acute injuries or illnesses.
排除标准
- •Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease.
- •Subjects who had had an MI within 14 days prior to the PCI procedure.
- •Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD).
- •Subjects with history of TIA/stroke within 90 days or any intracranial bleed.
- •Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal.
- •Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements.
- •Subjects with a history of alcohol or drug abuse.
- •Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
- •Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct.
- •Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results.
- •Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.
研究组 & 干预措施
Low dose
Experimental
干预措施: CMX-2043 (Drug)
Mid Dose
Experimental
干预措施: CMX-2043 (Drug)
High Dose
Experimental
干预措施: CMX-2043 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo control (Drug)
结局指标
主要结局
Safety as measured by changes in CK-MB
时间窗: within 24 hours
次要结局
- Cardiac biomarkers(within 24 hours)
- ST segment changes(within 24 hours)
研究者
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan ExtensionMetastatic Non-small Cell Lung CancerNCT06212752Merck Sharp & Dohme LLC39
进行中（未招募）
3 期
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)Metastatic Non-small Cell Lung CancerNCT05722015Merck Sharp & Dohme LLC377
终止
3 期
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic HyponatremiaHyponatremiaNCT01451411Cumberland Pharmaceuticals4
已完成
3 期
Fast-track LiveR: Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-testLiver FailureNCT01785082Humedics GmbH149
已完成
3 期
A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in AdultsObesityNCT00563368VIVUS LLC756