NCT00863707已完成4 期
A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 511
- 主要终点
- Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a Stage III or Stage IV renal impairment based on the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) glomerular filtration rate (GFR) classification
- •Subject has a diagnosis of Coronary Artery Disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity (Body Mass Index (BMI) > 30)
- •Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
- •Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson
排除标准
- •Subject has a history of an additional clinically significant illness, medical condition, or laboratory abnormality within 2 weeks prior to Screening
- •Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete
研究组 & 干预措施
Placebo
Placebo Comparator
Matching intravenous (IV) bolus injection
干预措施: Placebo (Drug)
Regadenoson
Experimental
0.4 mg/5 mL intravenous bolus injection
干预措施: Regadenoson (Drug)
结局指标
主要结局
Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)
时间窗: 24 hours post dose
The data represents the numbers of subjects reporting Serious TEAEs. TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug.
次要结局
未报告次要终点
研究者
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