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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

553 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral administration

2

dose level 1

Group Type EXPERIMENTAL

ataciguat (HMR1766)

Intervention Type DRUG

oral administration

3

dose level 2

Group Type EXPERIMENTAL

ataciguat (HMR1766)

Intervention Type DRUG

oral administration

4

dose level 3

Group Type EXPERIMENTAL

ataciguat (HMR1766)

Intervention Type DRUG

oral administration

5

Group Type ACTIVE_COMPARATOR

cilostazol

Intervention Type DRUG

oral administration

Interventions

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ataciguat (HMR1766)

oral administration

Intervention Type DRUG

placebo

oral administration

Intervention Type DRUG

cilostazol

oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No