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

Official Title: “A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of HMR1766 Assessing the Efficacy and Safety of 3 Doses of HMR1766 Versus Placebo With Cilostazol as a Calibrator, Administered for 26 Weeks in Patients With Peripheral Arterial Disease (PAD) Fontaine Stage II”

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.

Intervention(s) in this Clinical Trial

• Drug: ataciguat (HMR1766)
  • oral administration
• Drug: placebo
  • oral administration
• Drug: cilostazol
  • oral administration

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
• Experimental: 2
  • dose level 1
• Experimental: 3
  • dose level 2
• Experimental: 4
  • dose level 3
• Active Comparator: 5

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Secondary efficacy endpoint: percent change in the absolute claudication distance
  • Time Frame: 26 weeks
    Safety Issue?: No
• Safety endpoints: adverse events
  • Time Frame: study period
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

ICD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00443287

Study ID Number: DFI6174

ClinicalTrials.gov Identifier: NCT00443287

Health Authority: United States: Food and Drug Administration