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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
History of Changes

March 2, 2007
March 31, 2011
February 2007
October 2008   (final data collection date for primary outcome measure)
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 ]
Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline
Complete list of historical versions of study NCT00443287 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Secondary efficacy endpoint: percent change in the absolute claudication distance
  • Safety endpoints: adverse events
Not Provided
Not Provided
 
Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Intermittent Claudication
  • Drug: ataciguat (HMR1766)
    oral administration
  • Drug: placebo
    oral administration
  • Drug: cilostazol
    oral administration
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    dose level 1
    Intervention: Drug: ataciguat (HMR1766)
  • Experimental: 3
    dose level 2
    Intervention: Drug: ataciguat (HMR1766)
  • Experimental: 4
    dose level 3
    Intervention: Drug: ataciguat (HMR1766)
  • Active Comparator: 5
    Intervention: Drug: cilostazol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
553
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   France,   Poland,   Russian Federation,   South Africa
 
NCT00443287
DFI6174, EudraCT : 2006-004275-35
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD Sanofi
Sanofi
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP