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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01773174
Recruitment Status : Withdrawn
First Posted : January 23, 2013
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: dabigatran etexilate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : January 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: dabigatran etexilate
single dose treatment with dabigatran oral solution
Drug: dabigatran etexilate
age & weight adjusted equivalent of adult dose



Primary Outcome Measures :
  1. Ecarin clotting time (ECT) [ Time Frame: one day ]
  2. Factor IIa inhibition [ Time Frame: one day ]
  3. Incidence of all bleeding events [ Time Frame: 30 days ]
  4. Incidence of all adverse events [ Time Frame: 30 days ]
  5. Plasma concentrations of total dabigatran [ Time Frame: one day ]
  6. Plasma concentrations of free dabigatran [ Time Frame: one day ]
  7. Plasma concentrations of BIBR 1048 BS (Base) [ Time Frame: one day ]
  8. Plasma concentrations of BIBR 951 BS [ Time Frame: one day ]
  9. Plasma concentrations of BIBR 1087 SE (Acid) [ Time Frame: one day ]
  10. Activated prothrombin time (aPTT) [ Time Frame: one day ]

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773174


Locations
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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01773174     History of Changes
Other Study ID Numbers: 1160.145
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants