“Non profit study of phase II, randomized, double blind, placebo controlled, parallel groups dose-finding trial with 3 doses of betaine versus placebo in subjects affected by PAD (Peripheral Arterial Disease)” - VAS07BE

INTERVENTION: Product Name: betaine Pharmaceutical Form: Oral powder Pharmaceutical form of the placebo: Oral powder Route of administration of the placebo: Oral use CONDITION: Leriche‐Fontaine stage II PAD (Peripheral Arterial Disease) presenting symptoms of intermittent claudicatio ; MedDRA version: 12.0 Level: LLT Classification code 10034633 Term: Peripheral vascular disease PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the best dosage of Betaine to be used in PAD (Peripheral Arterial Occlusive Disease) in regard of clinical parameters. Primary end point(s): To evaluate the best dosage of Betaine to be used in the clinical treatment of subjects affected by PAD according to a dose‐response study model. Secondary Objective: • Secondary objectives are to select concentration dependent parameters which may be responsible of the MoA and to evaluate the safety of the product; • Evaluation of the product safety profile ; INCLUSION CRITERIA: 1. Male and female subjects with Leriche‐Fontaine stage II PAD presenting symptoms of intermittent claudication for at least 6 months. 2. Age between 50 and 80 years. 3. Objective evidence confirming the clinical diagnosis of PAD (ankle/brachial index < 0.9 and, in diabetic patients, toe index <0.7). 4. Absolute claudication distance < 700, and initial claudication distance > 50 m in the standardized treadmill testing. 5. Clinical stability before inclusion (i.e. changes in ACD not exceeding 25 % in two standardized treadmill testings during run‐in). 6. Signed informed content, willing and able to comply with all procedures and scheduled visits 7. Availability for the planned study duration. 8. Negative pregnancy testing for women of childbearing potential (to be made during the screening phase and just before the first administration) and use of an acceptable means of contraception (condom, hormonal or mechanical methods) for one month prio