Mixed Antagonist of Serotonin for Claudication Optimal Therapy

Double-Blind, Double-Dummy, Randomized, Parallel Group Trial of SL650472 (Three Dose Regimens Versus Placebo and Cilostazol), for 24-Week Improvement of Walking Distance in Patients With Stage II Peripheral Arterial Disease Who Benefit From Optimal Prevention Strategy Including Clopidogrel

To investigate in patients suffering from intermittent claudication due to Fontaine stage II PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of SL650472 to placebo, and to calibrate such effect versus cilostazol

Inclusion Criteria:

• 1. Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis origin (symptoms present for 6 months or longer and not significantly changed within the past 3 months);
• 2. ICD of 30 to 200 m at screening constant workload treadmill test
• 3. Doppler-measured pre-treadmill ABI of 0.90 or lower after 10 minutes of rest or, for patients with an ABI of greater than 1.3 (non-compressible arteries), a Toe-Brachial Index (TBI) of less than 0.7.

Exclusion Criteria:

• 1. Age below 40 years and/or onset of symptoms of PAD before the age of 40 years;
• 2. Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome);
• 3. Limb-threatening (grades III and IV) chronic limb ischemia, manifested by ischemic rest pain, ulceration, or gangrene.
• 4. Patients with a history of malignant or proliferate breast disease.