Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 5/19/2018 |
| Start Date: | February 2007 |
| End Date: | October 2008 |
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.
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.
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