Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Intermittent Claudication

In brief

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.

Key facts

Study ID

NCT00443287

Run by

Sanofi

People needed

553

Starts

2007-02-01

Expected to finish

2008-10-01

Last updated by the study team

2018-05-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Midrand, South Africa

Full record on ClinicalTrials.gov

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