NCT01684423

Oral Rivaroxaban in Children With Venous Thrombosis

30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.

Conditions

• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
DRUG	Active comparator	Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).
DRUG	Rivaroxaban (BAY59-7939) suspension	Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.

Timeline

• Start date: 2013-02-19
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2012-09-13
• Last updated: 2017-09-21
• Results posted: 2017-09-21

Locations

59 sites across 10 countries: United States, Australia, Austria, Canada, France, Germany, Israel, Italy, Netherlands, Switzerland

Regulatory

• FDA-regulated drug study