Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease
Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease
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.
Inclusion Criteria:

 -  Patient with stable symptoms of intermittent claudication of the lower extremities,
 secondary to chronic occlusive arterial disease from atherosclerosis etiology
 (symptoms present for 6 months or longer and not significantly changed within the past
 3 months)

 -  Initial claudication distance of 30 to 250 meters at screening constant workload
 treadmill test

 -  Confirmation of underlying Peripheral Arterial Disease (PAD) at screening

 -  Confirmation of symptom stability at randomization based on constant workload
 treadmill test performance

 -  The patient must have optimal cardiovascular risk prevention and appropriate
 management of PAD, including clopidogrel at the dose of 75mg per day, during the study
 period

 Exclusion Criteria:

 -  Patient participated in investigational clinical trials in the last month prior to
 screening

 -  Pregnant or breast-feeding woman or woman without documented double birth control
 measures for at least 3 months prior to randomization

 -  Symptoms of PAD before the age of 40 years

 -  Recent initiations or discontinuation of treatment by vasoactive agents (e.g.,
 pentoxifylline, berprost sodium, papverine, isoxsuprine, nylidrin, cyclandelate, and
 niacin derivatives). Patients treated by cilostazol within 3 months prior to screening
 will also be excluded

 -  Recent lower-extremity surgical or endovascular arterial reconstructions or
 sympathectomy, or recent deep venous thrombosis

 -  Recent occurrence of at least one of the following: acute myocardial infarction,
 unstable angina, coronary artery bypass graft, percutaenous coronary intervention,
 transient ischemic attack or stroke

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.