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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00443287
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : May 17, 2018
Information provided by (Responsible Party):

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

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Study Type : Interventional  (Clinical Trial)
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 : February 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol

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

Primary Outcome Measures :
  1. 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 Measures :
  1. Secondary efficacy endpoint: percent change in the absolute claudication distance [ Time Frame: 26 weeks ]
  2. Safety endpoints: adverse events [ Time Frame: study period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00443287

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Vienna, Austria
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Warszawa, Poland
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sponsors and Collaborators
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Study Director: ICD Sanofi
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Responsible Party: Sanofi Identifier: NCT00443287    
Other Study ID Numbers: DFI6174
EudraCT : 2006-004275-35
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by Sanofi:
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Enzyme Activators