Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients - Full Text View

Sponsor:	Bayer
Collaborator:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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: Xarelto (Rivaroxaban, BAY59-7939) Drug: Enoxaparin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	MAGELLAN - Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin

Resource links provided by NLM:

Drug Information available for: Rivaroxaban Enoxaparin Sodium

U.S. FDA Resources

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 ]

Enrollment:	8101
Study Start Date:	December 2007
Study Completion Date:	November 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

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

Detailed Description:

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

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

Show 672 Study Locations

Sponsors and Collaborators

Bayer

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

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00571649 History of Changes
Other Study ID Numbers:	12839, EudraCT: 2007-004614-14
Study First Received:	December 11, 2007
Last Updated:	May 13, 2011
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

Additional relevant MeSH terms:

Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
Anticoagulants

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012