Pharmacological effects of oral L-citrulline and tetrahydrobiopterin in patients with peripheral artery disease: effects on walking distance, arterial and endothelial function.

ational Health and Medical Research Council (NHMRC)0 个研究点目标入组 50 人开始时间: 2009年10月9日最近更新: 2020年1月13日

试验速览

暂无简介。

•Male and postmenopausal women
•6 months of stable intermittent claudication
•Peripheral artery disease (PAD) secondary to atherosclerosis
•Resting ankle brachial index (ABI) <0.9 and at least 25% decrease with exercise
•Capacity to walk more than 2 but less than 12 mins on a treadmill
•<25% difference in walking distance on treadmill exercise test between 2 baseline studies
•No change in medications or physical activity within 3 months of enrollment

•Women of child-bearing potential;
•Current enrollment in another clinical trial and/or ingestion of another trial agent within 30days of enrollment;
•Peripheral artery disease (PAD) of non-atherosclerotic nature;
•Fontaine class IV (4);
•Leg amputation above ankle;
•Peripheral vascular surgery, sympathectomy, angioplasty and/or stent insertion within previous 3 months;
•Myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within pervious 3 months;
•Uncontrolled hypertension;
•Type I diabetes;
•Proliferative retinopathy;
•History of disease state or surgery affecting gastrointestinal absorption;
•Significant renal disease;
•Liver disease;
•History of treatment for any malignancy within past 5 years or evidence of active malignancy other than squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) of skin;
•Serious infection or hypotension associated with sepsis in previous month;
•Stroke within past 3 months;
•Autoimmune disorder;
•Any other acute or chronic medical condition which, in the opinion of the investigator, will increase the liklihood of the subject being unable to complete the study;
•Unwillingness to discontinue arginine or citrulline containing products, pentoxifylline, L-carnitine or prostacycline for at least 1 month prior to the study;
•Walking distance limited by conditions other than peripheral artery disease (PAD).

发起方

ational Health and Medical Research Council (NHMRC)