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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00174759 |
Purpose
Primary objective:
To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD.
Secondary objectives:
Comparison, between the two treatment groups, of :
| Condition | Intervention | Phase |
|---|---|---|
|
Arterial Occlusive Diseases |
Drug: Clopidogrel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized Study of Clopidogrel 75 mg/d vs Placebo, on a Background of ASA 75-100 mg/d,in Peripheral Arterial Disease (PAD) Patients Receiving a Unilateral Below Knee Bypass Graft. |
| Estimated Enrollment: | 1460 |
| Study Start Date: | September 2004 |
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: A patient is eligible for inclusion in the study 2-4 days after surgery if all the following criteria are fulfilled:
Exclusion criteria :
PAD medical/surgical history
Medical history related to bleeding risk
Other medical conditions
Contacts and Locations| Australia | |
| Sanofi-Aventis | |
| North Ryde, Australia | |
| Austria | |
| Sanofi-Aventis | |
| Vienna, Austria | |
| Belgium | |
| Sanofi-Aventis | |
| Brussels, Belgium | |
| Finland | |
| Sanofi-Aventis | |
| Helsinki, Finland | |
| France | |
| Sanofi-Aventis | |
| Paris, France | |
| Germany | |
| Sanofi-Aventis | |
| Berlin, Germany | |
| Hungary | |
| Sanofi-Aventis | |
| Budapest, Hungary | |
| Italy | |
| Sanofi-Aventis | |
| Milan, Italy | |
| Netherlands | |
| Sanofi-Aventis | |
| Gouda, Netherlands | |
| Poland | |
| Sanofi-Aventis | |
| Warsaw, Poland | |
| Spain | |
| Sanofi-Aventis | |
| Barcelona, Spain | |
| Sweden | |
| Sanofi-Aventis | |
| Stockholm, Sweden | |
| Switzerland | |
| Sanofi-Aventis | |
| Meyrin, Switzerland | |
| United Kingdom | |
| Sanofi-Aventis | |
| Guildford, United Kingdom | |
| Study Director: | Luc Sagnard | Sanofi-Aventis |
More Information
| ClinicalTrials.gov Identifier: | NCT00174759 History of Changes |
| Other Study ID Numbers: | C_9253, EudraCT #: 2004-000822-58 |
| Study First Received: | September 9, 2005 |
| Last Updated: | January 10, 2011 |
| Health Authority: | Scotland: Scottish Executive Health Department |
|
Arterial Occlusive Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Atherosclerosis Arteriosclerosis Aspirin Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Purinergic P2Y Receptor Antagonists |