Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

This study is currently recruiting participants.

Verified by Bayer, January 2009

Sponsors and Collaborators:	Bayer Johnson & Johnson Pharmaceutical Research & Development, L.L.C. - within the U.S., Johnson&Johnson is sponsor
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00571649

Purpose

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin	Phase III

Drug Information available for: Enoxaparin Sodium Rivaroxaban

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	MAGELLAN - Multicenter, rAndomized, Parallel Group Efficacy Superiority Study in Hospitalized Medically iLL Patients Comparing rivaroxabAN With Enoxaparin

Further study details as provided by Bayer:

Primary Outcome Measures:

Composite of VTE (DVT and/or PE) and Death [ Time Frame: up to day 35 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Individual components of the composite endpoint and other cardiovascular events. [ Time Frame: 90 + 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	8000
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Rivaroxaban (BAY59-7939) Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days
Arm 2: Active Comparator	Drug: Enoxaparin Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients aged 40 years or more
Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:
Heart failure, NYHA class III or IV
Active cancer
Acute ischemic stroke
Acute infectious and inflammatory diseases, including acute rheumatic diseases
Acute respiratory insufficiency
Additional risk factor for VTE, including reduced mobility

Exclusion Criteria:

Conditions that contraindicate the use of antithrombotic therapy with the LMWH enoxaparin
Conditions that may increase the risk of bleeding, including intracranial hemorrhage
Required drugs or procedures which may interfere with the study treatment
Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
General conditions in which subjects are not suitable to participate in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571649

Contacts

Contact: Bayer Clinical Trial Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+) 1-888-842-2937

Show 498 Study Locations

Sponsors and Collaborators

Bayer

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

- within the U.S., Johnson&Johnson is sponsor

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12839, EudraCT: 2007-004614-14, MAGELLAN
Study First Received:	December 11, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00571649
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Acute medical illnesses with increased risk for VTE.
Deep vein thrombosis (DVT)
Pulmonary embolism (PE),
Venous Thromboembolic disease (VTE),
Medical illness

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Embolism
Vascular Diseases
Venous Thrombosis

Venous Thromboembolism
Thromboembolism
Thrombosis
Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009