NCT01507051

Switching Study From Warfarin to Rivaroxaban

Randomized, Placebo-controlled, Parallel-group Study in Healthy Male Subjects to Investigate the Pharmacodynamics During the Switching Procedure From Warfarin to Rivaroxaban

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Warfarin (Coumadin)	Days -6 and -5: 10 mg warfarin (Coumadin) once daily, dosage lower if the INR is already high on day -5; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin (Coumadin) once daily, dosage depending on INR
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Days 0 to 3: 20 mg rivaroxaban once daily
DRUG	Placebo	Days 0 to 3: 1 tablet placebo, identical to active tablet
DRUG	Vitamin K (Konakion)	Day 5: 10 mg vitamin K (Konakion) once daily

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2012-01-10
• Last updated: 2015-02-09
• Results posted: 2012-04-26

Locations

2 sites across 1 country: Germany