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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00443287

Collaborator

(none)

553

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Claudication	Drug: ataciguat (HMR1766) Drug: placebo Drug: cilostazol	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

553 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: placebo oral administration
Experimental: 2 dose level 1	Drug: ataciguat (HMR1766) oral administration
Experimental: 3 dose level 2	Drug: ataciguat (HMR1766) oral administration
Experimental: 4 dose level 3	Drug: ataciguat (HMR1766) oral administration
Active Comparator: 5	Drug: cilostazol oral administration

Outcome Measures

Primary Outcome Measures

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

Secondary efficacy endpoint: percent change in the absolute claudication distance [26 weeks]
Safety endpoints: adverse events [study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Vienna		Austria
3	Sanofi-Aventis Administrative Office	Laval		Canada
4	Sanofi-Aventis Administrative Office	Paris		France
5	Sanofi-Aventis Administrative Office	Warszawa		Poland
6	Sanofi-Aventis Administrative Office	Moscow		Russian Federation
7	Sanofi-Aventis Administrative Office	Midrand		South Africa