NCT01252810已完成2 期
A Phase 2, Double-Blind, Randomized, Safety Study of GE-145 320 mg I/mL Injection Versus Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Artery Catheterization Procedure
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
- 284
- 试验地点
- 1
- 主要终点
- Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
研究概览
简要总结
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
- •The subject has at least one of the following comorbidities:
- •Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
- •DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
- •CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.
排除标准
- •The subject has known allergies to either iodine or any ICM.
- •The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
- •The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
- •The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.
研究组 & 干预措施
GE 145 320mg I/ml injection
Experimental
干预措施: GE-145 (Drug)
Iopamidol 370mg I/ml injection
Active Comparator
干预措施: GE-145 (Drug)
结局指标
主要结局
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
时间窗: After the imaging date for either Ioforminol or Iopamidol.
Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.
次要结局
- To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration(Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.)
- Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections(2, 6 and 24 hours post Ioforminol and Iopamidol adminstration)
研究者
研究点 (1)
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