WHO ICTRP trial

Rivaroxaban for treatment in venous thrombosis in young children

EUCTR2014-000566-22-IE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2014-000566-22-IE
Public title Rivaroxaban for treatment in venous thrombosis in young children
Scientific title 30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in young children with various manifestations of venous thrombosis - EINSTEIN Junior Phase II-part B: oral rivaroxaban in young children with venous
Primary sponsor Bayer HealthCare AG
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;Hong Kong;Finland;Spain;Ireland;Austria;Russian Federation;Israel;Italy;Switzerland;United…
Conditions Venous Thrombosis MedDRA version: 18.0 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Interventions Product Name: Xarelto Product Code: BAY59-7939 Pharmaceutical Form: Oral suspension INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration unit: mg/ml milligram(s)/millilitre Concentration…
Registration date May 15, 2014
Target size 20
Secondary IDs BAY59-7939/14374
Registry page clinicaltrialsregister.eu

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