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Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT)

NCT ID: NCT01855100

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-12-31

Brief Summary

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The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.

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Detailed Description

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Conditions

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Venous Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rivaroxaban

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients with a diagnosis of deep vein thrombosis (DVT) within the past 9 months, enabling at least 3 months of therapy

Exclusion Criteria

* Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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XA1314BE

Identifier Type: OTHER

Identifier Source: secondary_id

16852

Identifier Type: -

Identifier Source: org_study_id

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