EUCTR2006-001368-22-IS进行中（未招募）1 期
A randomized, double blind, placebo controlled phase II evaluation of the pharmacokinetics, pharmacodynamics and safety of DG-041 in PAD patients - N/A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
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
- •1. Male or female over the age of 40.
- •2. Diagnosed PAD with IC that has been stable for at least 6 months.
- •3. Fontaine class of IC of II-III.
- •4. ABI < 0.9 on at least one side.
- •5. Signed informed consent form.
- •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
- •1.Women of childbearing potential (i.e. not surgically sterile or at least 2 years postmenopausal).
- •2.Serum creatinine above 2 × upper limit of normal (ULN).
- •3.Active liver disease or aspartate transaminase (AST) and alanine transaminase (ALT) above 3 × ULN.
- •4.Recent (i.e. within 3 months) revascularization or other surgical procedures.
- •5.History of myocardial infarction or stroke within 3 months prior to randomization.
- •6.Active treatment with other antiplatelet drugs (specifically, clopidogrel and cilostazol) for 3 months prior to enrollment (patients are allowed to take ASA [75 mg daily] or other non-steroidal anti-inflammatory drugs, lipid lowering drugs and antihypertensives).
- •7.Active malignant disease (excluding basal cell carcinoma).
- •8.Any disease or condition that in the judgment of the investigator would interfere with the patient’s ability to participate in the trial.
- •9.Unable or not willing to sign informed consent form.
研究者
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