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239 : Dabigatran Etexilate in Children with Venous Thromboembolism: Results of the Open-Label, Phase IIb/III, Randomized Diversity Clinical Trial

Researchers

Presenter

  • Jacqueline Halton

Principal Investigators

  • Leonardo R. Brandao

  • Matteo Luciani

  • Lisa Bomgaars

  • Elizabeth Chalmers

  • Lesley Mitchell

  • Ildar Nurmeev

  • Anjali Sharathkumar

  • Pavel Svirin

  • Kirill Gorbatikov

  • Igor Tartakovsky

  • Monika Simetzberger

  • Fenglei Huang

  • Zhichao Sun

  • Jrg Kreuzer

  • Savion Gropper

  • Martina Brueckmann

  • Manuela Albisetti

Medical Centers

  • University of Ottawa, Children's Hospital of Eastern Ontario, Ontario, Ontario, Canada

  • Haematology/Oncology, Hospital for Sick Children, Toronto, ON, Canada

  • Pediatric Hematology/Oncology Department, Pediatric Hospital Bambino Gesù, Rome, Italy

  • Department of Pediatrics, Texas Children’s Cancer Center, Baylor College of Medicine, Houston, TX

  • Royal Hospital for Sick Children, Glasgow, United Kingdom

  • Pediatric Hospital, Kazan, Republic Tatarstan, Russian Federation

  • Stead Family Dept. of Pediatrics, University of Iowa Hospitals and Clinics, Iowa City, IA

  • Pediatric Hematology Department, Municipal Children’s Hospital ‘Morozovskaya’, Moscow, Russian Federation

  • Pediatric Cardiovascular Surgery, Regional hospital #1, Tyumen region, Russian Federation

  • Therapeutic Area Cardiovascular Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany

  • Department of Clinical Development, Boehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria

  • Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, United States

  • Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

  • Regional Operating Unit South East Asia and South Korea, Boehringer Ingelheim Singapore Pte. Ltd, The Concourse, Singapore

  • Therapeutic Area Cardiovascular Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany

  • Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany

  • Hematology Department, University Children’s Hospital, Zürich, Switzerland

Locations

  • Canada

  • Italy

  • United States

  • United Kingdom

  • Russia

  • Germany

  • Austria

  • Singapore

  • Switzerland

Companies

  • N/A

Study Components

Therapeutic Area

  • Cardiovascular (CVS)

  • Blood/haematological Diseases

  • Pulmonary/Respiratory Diseases

Disease

  • Venous thrombosis

Biomarkers

  • N/A

Drug/Treatment

  • Heparin

  • Pradax

  • Heparin

Outcome

  • N/A

Study Design

  • Randomized

  • Pharmacokinetics

  • Pharmacodynamics

  • Open Label

  • Multicenteric

  • Controlled

Phase

  • II

Study Id's

  • NCT01895777

Sponsors

  • N/A

Result

  • N/A

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