NCT00358826已完成2 期
Clinical Study Protocol No. VIA-2291-01, A Phase 2 Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-ranging Study of the Effect of VIA-2291 on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event
Tallikut Pharmaceuticals, Inc.12 个研究点 分布在 2 个国家目标入组 191 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 191
- 试验地点
- 12
- 主要终点
- Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
研究概览
简要总结
This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events
详细描述
This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients are to be of non-childbearing potential
- •Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI, or unstable angina 21 days (±3 days) prior to study randomization
- •Patient has documented coronary artery disease
排除标准
- •Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
- •Cirrhosis, recent hepatitis, ALT >1.5 x ULN or ALT > 1 x ULN and at least one other liver function test
- •Uncontrolled diabetes mellitus within 1 month prior to study screening
- •Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
- •Previous coronary artery bypass graft (CABG) surgery
- •Planned additional cardiac intervention
- •Recurrence of ST elevation MI, non-ST elevation MI, or unstable angina less than 18 days prior to randomization
- •Current atrial fibrillation, atrial flutter, or frequent premature ventricular contractions
- •Acetaminophen use in any form in the 7 days before enrollment
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
VIA-2291 25 mg
Experimental
VIA-2291 25 mg
干预措施: VIA-2291 (Drug)
VIA-2291 50 mg
Experimental
VIA-2291 50 mg
干预措施: VIA-2291 (Drug)
VIA-2291 100 mg
Experimental
VIA-2291 100 mg
干预措施: VIA-2291 (Drug)
结局指标
主要结局
Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
时间窗: Baseline and 12 weeks
次要结局
- Change From Baseline in Leukotriene E4 (LTE4)(Baseline and 12 weeks)
- Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study(Baseline and 12 weeks)
研究者
研究点 (12)
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