Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00443287

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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:

Drug Information available for: Cilostazol Ataciguat

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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
1: Placebo Comparator	Drug: placebo oral administration
2: Experimental dose level 1	Drug: ataciguat (HMR1766) oral administration
3: Experimental dose level 2	Drug: ataciguat (HMR1766) oral administration
4: Experimental dose level 3	Drug: ataciguat (HMR1766) oral administration
5: Active Comparator	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

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-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DFI6174, EudraCT : 2006-004275-35
Study First Received:	March 2, 2007
Last Updated:	October 16, 2009
ClinicalTrials.gov Identifier:	NCT00443287 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Russia: Ministry of Health and Social Development of the Russian Federation; Austria: Federal Ministry for Health and Women

Keywords provided by Sanofi-Aventis:

Peripheral
Artery
Disease

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Arteriosclerosis
Neuroprotective Agents
Signs and Symptoms
Fibrin Modulating Agents
Therapeutic Uses
Cardiovascular Diseases
Arterial Occlusive Diseases
Cilostazol

Peripheral Vascular Diseases
Vascular Diseases
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Intermittent Claudication
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on March 18, 2010