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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01855100
Other study ID # 16852
Secondary ID XA1314BE
Status Completed
Phase N/A
First received May 14, 2013
Last updated January 17, 2017
Start date July 2013
Est. completion date December 2014

Study information

Verified date January 2017
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rivaroxaban (Xarelto, BAY59-7939)
Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Bayer Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with major bleedings up to 1 year or 30 days after end of rivaroxaban
Primary Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE) up to 1 year or 30 days after end of rivaroxaban
Primary All-cause mortality up to 1 year or 30 days after end of rivaroxaban
Primary Adverse events up to 1 year or 30 days after end of rivaroxaban
Primary Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) up to 1 year or 30 days after end of rivaroxaban
Primary Quantities of resource use consumption up to 1 year or 30 days after end of rivaroxaban
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