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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00443287
First received: March 2, 2007
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Intermittent Claudication
Drug: ataciguat (HMR1766)
Drug: placebo
Drug: cilostazol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy endpoint: percent change in the absolute claudication distance [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Safety endpoints: adverse events [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Enrollment: 553
Study Start Date: February 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443287

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
France
Sanofi-Aventis Administrative Office
Paris, France
Poland
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
Sanofi
Investigators
Study Director: ICD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00443287     History of Changes
Other Study ID Numbers: DFI6174, EudraCT : 2006-004275-35
Study First Received: March 2, 2007
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation
Austria: Federal Ministry for Health and Women

Keywords provided by Sanofi:
Peripheral
Artery
Disease

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014