Status:
COMPLETED
Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease
Lead Sponsor:
Sanofi
Conditions:
Intermittent Claudication
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
553 Patients enrolled
Trial Details
Trial ID
NCT00443287
Start Date
February 1 2007
End Date
October 1 2008
Last Update
May 17 2018
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Vienna, Austria
3
Sanofi-Aventis Administrative Office
Laval, Canada
4
Sanofi-Aventis Administrative Office
Paris, France