check_circleStudy Completed
Venous thrombosis
Bayer Identifier:
10849
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Switching study from warfarin to rivaroxaban
Trial purpose
The study objective is to investigate the pharmacodynamics (effects of a drug product) when switching the treatment from warfarin to rivaroxaban.
84 young, healthy subjects will participate; they will be treated following a randomized, parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind (Treatments A and B) design.
The first two groups (A, B) will receive warfarin for approximately one week to adjust their blood coagulation values to a specific level, i.e. to maintain an INR (international normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant treatment.
The first group (A) will receive rivaroxaban for four days, the second group (B) will take placebo. On the last day, all subjects in groups A and B will receive vitamin K to neutralize the effects of warfarin. The third group (C) will not undergo prior treatment with warfarin but will receive rivaroxaban for four days.
84 young, healthy subjects will participate; they will be treated following a randomized, parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind (Treatments A and B) design.
The first two groups (A, B) will receive warfarin for approximately one week to adjust their blood coagulation values to a specific level, i.e. to maintain an INR (international normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant treatment.
The first group (A) will receive rivaroxaban for four days, the second group (B) will take placebo. On the last day, all subjects in groups A and B will receive vitamin K to neutralize the effects of warfarin. The third group (C) will not undergo prior treatment with warfarin but will receive rivaroxaban for four days.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
96Trial Dates
November 2008 - November 2009Phase
Phase 1Could I Receive a placebo
YesProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | MEDA Manufacturing GmbH, ClinPharmCologne | Köln, 51063, Germany |
Completed | CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach, 41061, Germany |
Primary Outcome
- Emax (maximum effect) on Prothrombin Time (PT) (coagulation test)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax,BA (baseline adjusted maximum effect) on Prothrombin time (coagulation test)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
Secondary Outcome
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of Prothrombin time (coagulation test)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUCBA(0-tn) (baseline adjusted area under the measurement versus time curve from time 0 to the last data point) of Prothrombin time (coagulation test)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax on PT (measured as INR=International Normalized Ratio)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) for PT (measured as INR=International Normalized Ratio)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax on Factor Xa activitydate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the inverse measurement versus time curve from time 0 to the last data point) of Factor Xa activitydate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on anti-Factor Xa activitydate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of anti-Factor Xa activitydate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on aPTT (activated partial thromboplastin time)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of aPTT (activated partial thromboplastin time)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on HepTest (coagulation test)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of HepTest (coagulation test)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on PiCT (prothrombinase-induced clotting time)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of PiCT (prothrombinase-induced clotting time)date_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on ETP (endogenous thrombin potential) AUCdate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of ETP (endogenous thrombin potential) AUCdate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on ETP (endogenous thrombin potential) lag timedate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of ETP (endogenous thrombin potential) lag timedate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on ETP (endogenous thrombin potential) peakdate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of ETP (endogenous thrombin potential) peakdate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on ETP (endogenous thrombin potential) peak timedate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of ETP (endogenous thrombin potential) peak timedate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on Factor VIIa activitydate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of Factor VIIa activitydate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Emax (maximum effect) on Factor IIa activitydate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of Factor IIa activitydate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placeboenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration versus time curve from time 0 to 24 hours [AUC(0-24)] of rivaroxaban after first dosedate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxabanenhanced_encryptionNoSafety Issue:
- Maximum drug concentration in plasma (Cmax) of rivaroxaban after first dosedate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxabanenhanced_encryptionNoSafety Issue:
- Half life associated with terminal slope (t1/2) of R-warfarin after the last dose of warfarindate_rangeTime Frame:Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarinenhanced_encryptionNoSafety Issue:
- Half life associated with terminal slope (t1/2) of S-warfarin after the last dose of warfarindate_rangeTime Frame:Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarinenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration versus time curve from time 0 to 24 hours divided by dose per kg body weight [AUC(0-24)norm] of rivaroxaban after first dosedate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxabanenhanced_encryptionNoSafety Issue:
- Maximum drug concentration in plasma divided by dose per kg body weight (Cmax,norm) of rivaroxaban after first dosedate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxabanenhanced_encryptionNoSafety Issue:
- Time to reach maximum drug concentration in plasma (tmax) of rivaroxaban after first dosedate_rangeTime Frame:0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxabanenhanced_encryptionNoSafety Issue:
- Drug concentration in plasma at expected time of maximum (peak) concentration (Cpeak) of rivaroxaban after second to fourth dosedate_rangeTime Frame:Always 3 h after second, third, and fourth doseenhanced_encryptionNoSafety Issue:
- Drug concentration in plasma at expected time of minimum (trough) concentration (Ctrough) of rivaroxaban after second to fourth dosedate_rangeTime Frame:Always 24 h after the second, third, and fourth doseenhanced_encryptionNoSafety Issue:
- Half life associated with terminal slope (t1/2) of rivaroxaban after last dosedate_rangeTime Frame:3, 24, 48, and 72 h after the last administration of rivaroxabanenhanced_encryptionNoSafety Issue:
- Drug concentration in plasma at steady state at expected time of minimum (trough) concentration (Ctrough,ss) of R-warfarin after the last dose of warfarindate_rangeTime Frame:0 h (predose) and 24 h after the last administration of warfarinenhanced_encryptionNoSafety Issue:
- Drug concentration in plasma at steady state at expected time of minimum (trough) concentration, normalized by dose (Ctrough,ss/D) of R-warfarin after the last dose of warfarindate_rangeTime Frame:0 h (predose) and 24 h after the last administration of warfarinenhanced_encryptionNoSafety Issue:
- Drug concentration in plasma at steady state at expected time of minimum (trough) concentration (Ctrough,ss) of S-warfarin after the last dose of warfarindate_rangeTime Frame:0 h (predose) and 24 h after the last administration of warfarinenhanced_encryptionNoSafety Issue:
- Drug concentration in plasma at steady state at expected time of minimum (trough) concentration, normalized by dose (Ctrough,ss/D) of S-warfarin after the last dose of warfarindate_rangeTime Frame:0 h (predose) and 24 h after the last administration of warfarinenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
3Additional Information
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