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Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: January 18, 2013
Last updated: October 23, 2015
Last verified: October 2015
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group

Condition Intervention Phase
Venous Thromboembolism Drug: dabigatran etexilate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Ecarin clotting time (ECT) [ Time Frame: one day ]
  • Factor IIa inhibition [ Time Frame: one day ]
  • Incidence of all bleeding events [ Time Frame: 30 days ]
  • Incidence of all adverse events [ Time Frame: 30 days ]
  • Plasma concentrations of total dabigatran [ Time Frame: one day ]
  • Plasma concentrations of free dabigatran [ Time Frame: one day ]
  • Plasma concentrations of BIBR 1048 BS (Base) [ Time Frame: one day ]
  • Plasma concentrations of BIBR 951 BS [ Time Frame: one day ]
  • Plasma concentrations of BIBR 1087 SE (Acid) [ Time Frame: one day ]
  • Activated prothrombin time (aPTT) [ Time Frame: one day ]

Secondary Outcome Measures:
  • Global assessment of tolerability will be summarized across all patients in the treated set [ Time Frame: 30 days ]
  • Patient assessment of taste will be summarized across all patients in the treated set [ Time Frame: one day ]
  • Changes in laboratory and clinical parameters [ Time Frame: 30 days ]

Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dabigatran etexilate
single dose treatment with dabigatran oral solution
Drug: dabigatran etexilate
age & weight adjusted equivalent of adult dose


Ages Eligible for Study:   1 Year to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. males or females 1 to less than 2 years of age
  2. objective diagnosis of primary venous thromboembolism
  3. completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism
  4. written informed consent by parent (legal guardian) and patient assent (if applicable)

Exclusion criteria:

  1. weight less than 9 kg
  2. conditions associated with increased risk of bleeding
  3. patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01773174

United States, California
1160.145.00010 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
United States, Kentucky
1160.145.00009 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
United States, Massachusetts
1160.145.00008 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, Missouri
1160.145.00012 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, New Jersey
1160.145.00007 Boehringer Ingelheim Investigational Site
Newark, New Jersey, United States
United States, Pennsylvania
1160.145.0006 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
United States, Texas
1160.145.00001 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, Washington
1160.145.00011 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT01773174     History of Changes
Other Study ID Numbers: 1160.145
Study First Received: January 18, 2013
Last Updated: October 23, 2015

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on August 18, 2017