Bayer Rivaroxaban: BAY 59-7939/14374

Clinical Trial

Offered by: Nemours Children's Specialty Care, Pensacola
Location: Pensacola, Fla.

Trial Name

Bayer Rivaroxaban: BAY 59-7939/14374

What is the trial about?

The purpose of this study is to determine the safety and efficacy (how well it works) of rivaroxaban and also to evaluate the pharmacokinetics (PK-what the body does to the drug) and pharmacodynamics (PD-what the drug does to the body) of rivaroxaban oral suspension.

Who can participate?

Your child can take part in this study if he/she has a blood clot that was recently diagnosed and is between the ages of 6 months to less than 2 years old.

What is involved?

If your child meets the study entry requirements and you allow your child to participate in this research study, it is estimated that it will take up to four months to complete all of the study visits. Participation in this study involves 5 planned visits to the study site. These visits may last up to 4-8 hours.

Over the entire study, 7 blood samples via 4 blood draws will be taken and the total blood volume taken will be 10 ml (equal to approximately 2 teaspoons) if blood is taken by venipuncture or 22 ml (equal to approximately 4 teaspoons) if blood is taken by central venous line or peripheral catheter.

Over the entire study, two blood samples for a total of about 10 ml (equal to approximately 2 teaspoons) will be taken for safety measurements.

Contact Nemours Clinical Trials

Trial Name:

Bayer Rivaroxaban: BAY 59-7939/14374

IRB: 620890

Contact Information

(800) 354-5690