The primary objective is to investigate in patients suffering from intermittent claudication due to Fontaine stage II Peripheral Arterial Disease (PAD) whether a 26-week treatment by HMR1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of HMR1766 to placebo, and calibrating such effect versus cilostazol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
553
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Vienna, Austria
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Paris, France
Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline
Time frame: 26 weeks
Secondary efficacy endpoint: percent change in the absolute claudication distance
Time frame: 26 weeks
Safety endpoints: adverse events
Time frame: study period
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Sanofi-Aventis Administrative Office
Warsaw, Poland
Sanofi-Aventis Administrative Office
Moscow, Russia
Sanofi-Aventis Administrative Office
Midrand, South Africa