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Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: March 8, 2010
Last updated: February 23, 2016
Last verified: February 2016
To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

Condition Intervention Phase
Venous Thromboembolism
Drug: dabigatran etexilate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 Successive Groups of Children Aged 2 Years to Less Than 12 Years Followed by 1 Year to Less Than 2 Years

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Plasma concentrations of total dabigatran [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Plasma concentrations of free dabigatran [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Plasma concentrations of BIBR 1048 BS (Base) [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Plasma concentrations of BIBR 951 BS [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Plasma concentrations of BIBR 1087 SE (Acid) [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Activated prothrombin time (aPTT) [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Ecarin clotting time (ECT) [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Factor IIa inhibition [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Incidence of all bleeding events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of all adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global assessment of tolerability will be summarized across all patients in the treated set [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Patient assessment of taste will be summarized across all patients in the treated set [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Changes in laboratory and clinical parameters [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2010
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dabigatran etexilate
treatment with dabigatran oral solution as a single dose
Drug: dabigatran etexilate
Experimental dose chosen based on age and weight

Detailed Description:

Ages Eligible for Study:   1 Year to 11 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. males or females 1 to less than 12 years of age
  2. objective diagnosis of primary VTE
  3. completion of planned treatment course with LMWH or OAC for primary VTE
  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: NCT01083732

  Show 27 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT01083732     History of Changes
Other Study ID Numbers: 1160.89  2009-013618-29 
Study First Received: March 8, 2010
Last Updated: February 23, 2016
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
Italy: National Institute of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

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 December 09, 2016