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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Intermittent Claudication

Treatments: Drug: cilostazol; Drug: ataciguat (HMR1766); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00443287

DFI6174

EudraCT : 2006-004275-35

Details and patient eligibility

About

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.

Enrollment: 553 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

553 participants in 5 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

2

Experimental group

Description:

dose level 1

Treatment:

Drug: ataciguat (HMR1766)

3

Experimental group

Description:

dose level 2

Treatment:

Drug: ataciguat (HMR1766)

4

Experimental group

Description:

dose level 3

Treatment:

Drug: ataciguat (HMR1766)

5

Active Comparator group

Treatment:

Drug: cilostazol