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

Sanofi1 site in 1 country553 target enrollmentFebruary 2007

ConditionsIntermittent Claudication

Interventionsplacebo ataciguat (HMR1766)cilostazol

Drugsataciguat (HMR1766)placebo cilostazol

Overview

Phase: Phase 2
Intervention: placebo
Conditions: Intermittent Claudication
Sponsor: Sanofi
Enrollment: 553
Locations: 1
Primary Endpoint: Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

October 2008

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: placebo

2

dose level 1

Intervention: ataciguat (HMR1766)

3

dose level 2

Intervention: ataciguat (HMR1766)

4

dose level 3

Intervention: ataciguat (HMR1766)

5

Intervention: cilostazol

Outcomes

Primary Outcomes

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