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

Phase 2

Completed

• Conditions: Intermittent Claudication
• Interventions: Drug: placebo; Drug: ataciguat (HMR1766); Drug: cilostazol

• Registration Number: NCT00443287
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-02
• Study First Submitted QC: 2007-03-02
• Study First Posted: 2007-03-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2018-05
• Disposition First Submitted: 2018-05-03
• Disposition First Submitted QC: 2018-05-03
• Disposition First Posted: 2018-05-08
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 553

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
2	ataciguat (HMR1766)	dose level 1
3	ataciguat (HMR1766)	dose level 2
5	cilostazol	-
4	ataciguat (HMR1766)	dose level 3

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy endpoint: percent change in the absolute claudication distance	26 weeks
Safety endpoints: adverse events	study period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇿🇦 Midrand, South Africa