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

Intermittent Claudication Clinical Trial

— ACCELA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443287
• Other study ID #: DFI6174
• Secondary ID: EudraCT : 2006-0
• Status: Completed
• Phase: Phase 2
• Start date: February 2007
• Est. completion date: October 2008

Study information

• Verified date: May 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 553
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• ataciguat (HMR1766)
oral administration
• placebo
oral administration
• cilostazol
oral administration

Locations

Country	Name	City	State
Austria	Sanofi-Aventis Administrative Office	Vienna
Canada	Sanofi-Aventis Administrative Office	Laval
France	Sanofi-Aventis Administrative Office	Paris
Poland	Sanofi-Aventis Administrative Office	Warszawa
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
South Africa	Sanofi-Aventis Administrative Office	Midrand
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Poland,  Russian Federation,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline		26 weeks
Secondary	Secondary efficacy endpoint: percent change in the absolute claudication distance		26 weeks
Secondary	Safety endpoints: adverse events		study period