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Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer

NCT ID: NCT00786422

Last Updated: 2015-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-06-30

Brief Summary

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This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire 3-month study duration.

Detailed Description

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The following laboratory variables were determined at baseline at the local laboratories: Hemoglobin, platelets, activated partial thromboplastin time (aPTT), international normalized ratio (INR), alanine aminotransferase (ALT), and creatinine.

Conditions

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Venous Thrombosis Deep Vein Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rivaroxaban (Xarelto, BAY59-7939)

Group Type EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type DRUG

Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.

Interventions

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Rivaroxaban (Xarelto, BAY59-7939)

Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed acute symptomatic proximal deep- vein thrombosis and/or pulmonary embolism
* Concomitant use of a strong CYP 3A4 inducer, (i.e., carbamazepine, phenytoin, rifampicin/rifampin, and rifabutin)

Exclusion Criteria

* Legal lower age limitations (country specific)
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of deep -vein thrombosis and/or pulmonary embolism
* Other indication for vitamin K antagonist (VKA) than deep -vein thrombosis and/or pulmonary embolism
* Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole)
* Use of the strong CYP 3A4 inducers phenobarbital/primidone or St John's Wort
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

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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Redcliffe, Queensland, Australia

Site Status

Vienna, Vienna, Austria

Site Status

São Paulo, São Paulo, Brazil

Site Status

München, Bavaria, Germany

Site Status

Debrecen, , Hungary

Site Status

Ashkelon, , Israel

Site Status

Holon, , Israel

Site Status

Pavia, , Italy

Site Status

Amsterdam, , Netherlands

Site Status

Johannesburg, Gauteng, South Africa

Site Status

Johannesburg, Gauteng, South Africa

Site Status

Pretoria, Gauteng, South Africa

Site Status

Pretoria, Gauteng, South Africa

Site Status

Roodepoort, Gauteng, South Africa

Site Status

Somerset West, Western Cape, South Africa

Site Status

Worcester, Western Cape, South Africa

Site Status

Countries

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Australia Austria Brazil Germany Hungary Israel Italy Netherlands South Africa

Related Links

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http://www.clinicaltrialsregister.eu

Click here and search for information of Bayer products for Europe

Other Identifiers

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2008-003303-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13238

Identifier Type: -

Identifier Source: org_study_id