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CompletedNCT00443287ACCELAUpdated May 17, 2018

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

A Phase 2 interventional study of ataciguat (HMR1766) and placebo in Intermittent Claudication, sponsored by Sanofi. Completed at 7 sites in 7 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
553
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intermittent Claudication

Keywords

  • Peripheral
  • Artery
  • Disease
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 553 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
553 participants (actual)

Study arms

  • Placebo comparator
    1

    Drug: placebo

  • Experimental
    2

    dose level 1

    Drug: ataciguat (HMR1766)

  • Experimental
    3

    dose level 2

    Drug: ataciguat (HMR1766)

  • Experimental
    4

    dose level 3

    Drug: ataciguat (HMR1766)

  • Active comparator
    5

    Drug: cilostazol

Interventions

  • Drugataciguat (HMR1766)

    oral administration

  • Drugplacebo

    oral administration

  • Drugcilostazol

    oral administration

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Secondary efficacy endpoint: percent change in the absolute claudication distance

    Time frame: 26 weeks

  2. Safety endpoints: adverse events

    Time frame: study period

07

Study locations

7 sites
  • Sanofi-Aventis Administrative Office
    Bridgewater, New Jersey 08807, United States
  • Sanofi-Aventis Administrative Office
    Vienna, Austria
  • Sanofi-Aventis Administrative Office
    Laval, Canada
  • Sanofi-Aventis Administrative Office
    Paris, France
  • Sanofi-Aventis Administrative Office
    Warszawa, Poland
  • Sanofi-Aventis Administrative Office
    Moscow, Russian Federation
  • Sanofi-Aventis Administrative Office
    Midrand, South Africa
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00443287
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Mar 5, 2007
Start date
Feb 2007
Primary completion
Oct 2008
Completion
Oct 2008
Last update
May 17, 2018

Study contacts

ICD
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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