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

Primary Purpose

Intermittent Claudication

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ataciguat (HMR1766)

placebo

cilostazol

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring Peripheral, Artery, Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Arm Description

dose level 1

dose level 2

dose level 3

Outcomes

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

Secondary Outcome Measures

Secondary efficacy endpoint: percent change in the absolute claudication distance

Safety endpoints: adverse events

Full Information

NCT ID

NCT00443287

First Posted

March 2, 2007

Last Updated

May 15, 2018

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00443287

Brief Title

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

Acronym

ACCELA

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 Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intermittent Claudication

Keywords

Peripheral, Artery, Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

553 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Description

dose level 1

Arm Title

Arm Type

Experimental

Arm Description

dose level 2

Arm Title

Arm Type

Experimental

Arm Description

dose level 3

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

ataciguat (HMR1766)

Intervention Description

oral administration

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral administration

Intervention Type

Drug

Intervention Name(s)

cilostazol

Intervention Description

oral administration

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Secondary efficacy endpoint: percent change in the absolute claudication distance

Time Frame

26 weeks

Title

Safety endpoints: adverse events

Time Frame

study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

Facility Name

Sanofi-Aventis Administrative Office

City

Vienna

Country

Austria

Facility Name

Sanofi-Aventis Administrative Office

City

Laval

Country

Canada

Facility Name

Sanofi-Aventis Administrative Office

City

Paris

Country

France

Facility Name

Sanofi-Aventis Administrative Office

City

Warszawa

Country

Poland

Facility Name

Sanofi-Aventis Administrative Office

City

Moscow

Country

Russian Federation

Facility Name

Sanofi-Aventis Administrative Office

City

Midrand

Country

South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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