Venous Thrombosis Clinical Trial
Official title:
Randomized, Placebo-controlled, Parallel-group Study in Healthy Male Subjects to Investigate the Pharmacodynamics During the Switching Procedure From Warfarin to Rivaroxaban
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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