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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intermittent Claudication

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

Phase: Phase 2

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
ICD, Study Director, Affiliation: Sanofi


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline

Secondary outcome:

Secondary efficacy endpoint: percent change in the absolute claudication distance

Safety endpoints: adverse events


Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.


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


- 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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Vienna, Austria

Sanofi-Aventis Administrative Office, Laval, Canada

Sanofi-Aventis Administrative Office, Paris, France

Sanofi-Aventis Administrative Office, Warszawa, Poland

Sanofi-Aventis Administrative Office, Moscow, Russian Federation

Sanofi-Aventis Administrative Office, Midrand, South Africa

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States

Additional Information

Starting date: February 2007
Last updated: March 31, 2011

Page last updated: August 23, 2015

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