EUCTR2009-016823-74-SE进行中（未招募）不适用
An open pilot study to assess the effects of pemirolast on C-reactive protein levels in subjects with coronary artery disease.
Cardoz AB0 个研究点目标入组 12 人开始时间: 2009年11月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects with coronary artery disease (CAD):
- •a)CAD (diagnosed on the basis of a previous myocardial perfusion study or cardiac catheterisation, or a history of myocardial infarction or coronary angioplasty or coronary artery bypass surgery).
- •b)Male or female subjects aged 40 – 70 years. Body Mass Index between 19 and 29 kg/m2
- •c)Stable statin therapy since one month.
- •d)High sensitivity CRP (hs-CRP) >2.0 and <10.0 mg/L.
- •e)No change in cardiac medications since one month.
- •f)Female subjects have to be non-fertile, i.e. postmenopausal or surgically sterile.
- •g)In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol.
- •h)Subjects will have given their written informed consent to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with CAD:
- •a)Acute illness within the last two weeks.
- •b)Pharmacologically treated type 1 or type 2 diabetes mellitus.
- •c) Recent coronary events (within 3 months)
- •d)Clinical heart failure
- •e)Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiac, pulmonary, metabolic, endocrine, haematological, psychological or other major disorder as judged by the Investigator.
- •f)Pregnancy or breast feeding
- •g)Subjects who previously have demonstrated hypersensitivity to the investigational medicinal product.
- •h)Subjects atopic or with history of allergy as judged by the Investigator.
- •i)Subjects who have used any prescribed systemic, except prescribed statin and cardiovascular medications (beta blockers, calcium inhibitors, ACE-inhibitors, diuretics, clopidogrel (Plavix) and low dose trombyl) or topical medication within 14 days before the first dose administration.
- •j)Subjects who have used any OTC systemic or topical medication within 7 days before the first dose administration (with the exception of vitamin/mineral supplements, paracetamol, NSAIDs or nasal decongestants at the discretion of the Investigator).
- •k)Subjects who have participated in a clinical study involving administration of an investigational drug or a marketed drug within the past 3 months.
- •l)Subjects who have donated blood during the last 3 months or plasma the last month.
- •m)Subjects who have had a clinically significant illness within 4 weeks of the start of the study as judged by the Investigator.
- •n)Subjects who are known to have serum hepatitis or who are carriers of the hepatitis B surface antigen (HBsAg), or hepatitis C antibody, or have a positive result to the test for HIV antigens and/or antibodies.
- •o)Heavy smoker and/or excessive use of alcohol, as judged by the Investigator.
研究者
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