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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00786422
First received: November 5, 2008
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: December 20, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Venous Thrombosis
Deep Vein Thrombosis
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with confirmed acute proximal symptomatic deep vein thrombosis (DVT) or acute pulmonary embolism (PE) were recruited at specialized study sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 25 participants screened, 25 participants were assigned to treatment.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   Rivaroxaban Treatment
    Rivaroxaban (Xarelto, BAY59-7939)  
STARTED     25  
COMPLETED     14  
NOT COMPLETED     11  
Death                 2  
Final visit earlier than planned                 3  
Lack of Efficacy                 1  
Physician Decision                 1  
Withdrawal by Subject                 1  
Non-compliance with study drug treatment                 1  
Adverse Event                 2  

Period 2:   Follow-up Period
    Rivaroxaban (Xarelto, BAY59-7939)  
STARTED     20 [1]
COMPLETED     17  
NOT COMPLETED     3  
Death                 1  
End-of-study done up to 4 days early                 2  
[1] Participants entered follow-up period. No reason documents for those not entering this period



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Rivaroxaban (Xarelto, BAY59-7939)  
Number of Participants  
[units: participants]
  25  
Age, Customized  
[units: Participants]
 
< 65 years     23  
65 - 75 years     1  
> 75 years     1  
Gender  
[units: Participants]
 
Female     13  
Male     12  
Race  
[units: Participants]
 
White     1  
Black     23  
Other (mixed South African descent)     1  
Creatinine clearance [1]
[units: Participants]
 
<30 mL/min     0  
30 - <50 mL/min     0  
50 - <80 mL/min     4  
> 80 mL/min     21  
Region of recruitment  
[units: Participants]
 
South Africa - Yes     25  
South Africa - No     0  
Participants with history of tuberculosis  
[units: Participants]
 
History of tuberculosis     20  
No history of tuberculosis     5  
[1] Volume of blood plasma cleared of creatinine per time unit



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pharmacodynamics - Prothrombin Time (PT), Baseline Value   [ Time Frame: The baseline value of prothrombin time is measured or calculated at a rivaroxaban concentration of 0 µg/L and is based on the observations that were made during the 3 months treatment period ]

2.  Primary:   Pharmacodynamics - Prothrombin Time (PT), Slope   [ Time Frame: Up to 3 months treatment ]

3.  Primary:   Pharmacokinetics - AUC(0-24)ss (Area Under the Measurement Versus Time Curve From Time 0 to 24 Hours After First Dosing on a Day at Steady State) of Rivaroxaban   [ Time Frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban ]

4.  Primary:   Pharmacokinetics – Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban   [ Time Frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban ]

5.  Primary:   Pharmacokinetics – Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban   [ Time Frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban ]

6.  Primary:   Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)   [ Time Frame: Up to 3 months treatment and during subsequent 2 days ]

7.  Secondary:   Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Non-fatal or Fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment   [ Time Frame: Up to 3 months treatment and during subsequent 30-day observational period for an individual participant ]

8.  Secondary:   Percentage of Participants With All Deaths   [ Time Frame: Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month ]

9.  Secondary:   Percentage of Participants With Treatment Emergent Deaths - 7 Days Window   [ Time Frame: Up to 3 months treatment and during subsequent 7 days ]

10.  Secondary:   Percentage of Participants With Other Vascular Events   [ Time Frame: Up to 3 months treatment and during subsequent 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00786422     History of Changes
Other Study ID Numbers: 13238, 2008-003303-31
Study First Received: November 5, 2008
Results First Received: December 20, 2013
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration
South Africa: Medicine Control Council