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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00622648 |
The primary objective:
The secondary objective:
Condition | Intervention | Phase |
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Acute Illness |
Drug: Enoxaparin Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | International, Multi-Center, Randomized, Double Blind Study to Compare the Overall Mortality in Acutely Ill Medical Patients Treated With Enoxaparin Versus Placebo in Addition to Graduated Elastic Stockings |
Estimated Enrollment: | 8790 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Enoxaparin: 40 mg once daily for 6 to 14 days (10 ± 4 days)
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Drug: Enoxaparin
40 mg once daily for 6 to 14 days (10 ± 4 days)
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B: Placebo Comparator
Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)
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Drug: Placebo
Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
List of inclusion and exclusion criteria
Inclusion Criteria:
Hospitalization for at least one of the following medical acute medical illness:
Severe systemic infection and at least one of the following:
Health status:
Exclusion criteria:
Contraindication to anticoagulation:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact: Public Registry GMA | PublicRegistryGMA@sanofi-aventis.com |
Brazil | |
Sanofi-aventis Administrative Office | Withdrawn |
Sao Paulo, Brazil | |
China | |
Sanofi-aventis Administrative Office | Recruiting |
Shanghai, China | |
Hong Kong | |
Sanofi-aventis Administrative Office | Recruiting |
Hong Kong, Hong Kong | |
India | |
Sanofi-aventis Administrative Office | Recruiting |
Mumbai, India | |
Korea, Republic of | |
Sanofi-aventis Administrative Office | Recruiting |
Seoul, Korea, Republic of | |
Malaysia | |
Sanofi-aventis Administrative Office | Recruiting |
Kuala Lumpur, Malaysia | |
Mexico | |
Sanofi-aventis Administrative Office | Recruiting |
Col. Coyoacan, Mexico | |
Philippines | |
Sanofi-aventis Administrative Office | Recruiting |
Makati City, Philippines | |
Tunisia | |
Sanofi-aventis Administrative Office | Recruiting |
Megrine, Tunisia |
Study Director: | Bruno DESLANDES | Sanofi-Aventis |
Responsible Party: | Sanofi-aventis ( Medical affairs study director ) |
Study ID Numbers: | ENOXA_C_01249 |
Study First Received: | February 14, 2008 |
Last Updated: | June 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00622648 History of Changes |
Health Authority: | Malaysia: Ministry of Health |
Medical prevention therapy |
Fibrin Modulating Agents Anticoagulants Fibrinolytic Agents Cardiovascular Agents Enoxaparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Enoxaparin |