FindTrial
Sign In

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00443287
Acronym
ACCELA
Enrollment
553
Registered
2007-03-05
Start date
2007-02-28
Completion date
2008-10-31
Last updated
2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication

Keywords

Peripheral, Artery, Disease

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.

Interventions

DRUGataciguat (HMR1766)

oral administration

DRUGplacebo

oral administration

DRUGcilostazol

oral administration

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline26 weeks

Secondary

MeasureTime frame
Secondary efficacy endpoint: percent change in the absolute claudication distance26 weeks
Safety endpoints: adverse eventsstudy period

Countries

Austria, Canada, France, Poland, Russia, South Africa, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026