Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01855100
First received: May 14, 2013
Last updated: February 26, 2015
Last verified: February 2015

May 14, 2013
February 26, 2015
July 2013
November 2014   (final data collection date for primary outcome measure)
Real-life medical resource use consumption based on medical examination and patient diary cards [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01855100 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT)
Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto® Following an Acute Deep Vein Thrombosis (DVT)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Ambulatory or hospitalized patients coming from the vascular diseases clinic of the participating hospitals

Venous Thrombosis
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.
Rivaroxaban
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
December 2014
November 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01855100
16852, XA1314BE
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP