Status:
COMPLETED
Switching Study From Warfarin to Rivaroxaban
Lead Sponsor:
Bayer
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Venous Thrombosis
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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 wil...
Eligibility Criteria
Inclusion
- 18 to 45 years of age;
- Normal body weight: BMI (body mass index) between 18 and 29 kg/m2;
- Pharmacogenetics: subjects who are homozygous for the wildtype allele 2C9\*1 and who are carriers of the C-allele at positions 6484 and 7566 of the VKORC1 (vitamin K epoxide reductase) gene, respectively
Exclusion
- Relevant deviation from the normal range in the clinical examination;
- Relevant deviation from the normal range in clinical chemistry, hematology or urinalysis;
- Resting heart rate in the awake subject below 45 BPM (beats per minute) or above 90 BPM;
- Systolic blood pressure below 100 mmHg or above 140 mmHg; and Diastolic blood pressure above 85 mmHg;
- Relevant pathological changes in the ECG (electrocardiogram) such as a second or third-degree AV block, prolongation of the QRS (QRS complex in ECG) complex over 120 msec or of the QT / QTc-interval over 450 msec (QT interval in ECG, QTc interval corrected for heart rate);
- Subject is tested to be HIV-1/2Ab, p24Ag, HbsAg or HCV-Ab positive;
- Known coagulation disorders (e.g. von Willebrand's disease, haemophiliac);
- Known disorders with increased bleeding risks (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer);
- Known sensitivity to common causes of bleeding (e.g. nasal);
- Recent or planned surgical or diagnostic procedures at the central nervous system (CNS) or eye;
- Subjects with hyperlipidemia (Coumadin / warfarin warning)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01507051
Start Date
November 1 2008
End Date
November 1 2009
Last Update
February 9 2015
Active Locations (2)
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1
Cologne, North Rhine-Westphalia, Germany, 51063
2
Mönchengladbach, North Rhine-Westphalia, Germany, 41061