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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00443287 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 550 |
Study Start Date: | March 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: placebo
oral administration
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2: Experimental
dose level 1
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Drug: ataciguat (HMR1766)
oral administration
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3: Experimental
dose level 2
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Drug: ataciguat (HMR1766)
oral administration
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4: Experimental
dose level 3
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Drug: ataciguat (HMR1766)
oral administration
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5: Active Comparator |
Drug: cilostazol
oral administration
|
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
Study Director: | ICD | Sanofi-Aventis |
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, 2008 |
ClinicalTrials.gov Identifier: | NCT00443287 |
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 |
Peripheral Artery Disease |
Arterial Occlusive Diseases Cilostazol Signs and Symptoms Peripheral Vascular Diseases |
Vascular Diseases Intermittent Claudication Arteriosclerosis |
Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Protective Agents Neuroprotective Agents |
Pharmacologic Actions Fibrin Modulating Agents Phosphodiesterase Inhibitors Autonomic Agents Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |