NCT00291902已完成2 期
A 28-day, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 (7.5 mg) in Subjects With Coronary Heart Disease (CHD) Undergoing Elective Percutaneous Coronary Interventions (PCI)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)
研究概览
简要总结
Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females must be of non-child-bearing potential.
- •Female subjects must have a negative pregnancy test.
- •Subjects scheduled to undergo elective single vessel PCI to be performed within the 6 weeks of diagnostic coronary angiography.
- •Must be on stable dose of statin for = 6 weeks prior to screening, with statin tolerability and LDL <130 mg/dL (3.4 mmol/L) at Screening visit.
- •Must be capable of providing informed consent.
- •Have an hsCRP concentration of >2 mg/L, but < 10 mg/L at screening.
排除标准
- •Women who are pregnant or breast feeding.
- •Planned PCI with multi-vessel stenting.
- •Planned PCI with additional revascularization procedures staged at different days during the study period.
- •Planned PCI other than stenting (e.g., atherectomy, PTCA without stenting, etc).
- •Planned PCI of any bypass graft.
- •History of CABG surgery.
- •Planned cardiac or major non-cardiac surgery within the study period.
- •Disabling stroke in the past 6 months.
- •History of chronic viral hepatitis or other chronic hepatic disorders.
- •History of Gilbert's syndrome or elevated bilirubin concentrations at screening.
- •History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, above the upper limit of normal at screening or in the past 6 months.
- •Renal impairment with serum creatinine >2.0 mg/dl (177umol/L) at Screening, or history of kidney transplant, or a history of contrast nephropathy.
- •Current inadequately controlled hypertension (blood pressure >160 mmHg systolic and/or >100 mmHg diastolic) on a stable dose of antihypertensive medication.
- •Current poorly controlled diabetes mellitus, defined as HbA1c >10% at Screening.
- •History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction (EF<30%) regardless of symptomatic status.
- •History of malignancy within the past 5 years, other than non-melanoma skin cancer.
- •Current life-threatening condition other than vascular disease that may prevent a subject from completing the study.
- •Alcohol or drug abuse within the past 6 months.
结局指标
主要结局
Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein)
时间窗: 28 days
次要结局
- Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics(28 days)
研究者
研究点 (8)
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