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Safety and Tolerability of Dabigatran Etexilate in Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00844415
First Posted: February 16, 2009
Last Update Posted: June 9, 2014
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.

Condition Intervention Phase
Venous Thromboembolism Drug: dabigatran etexilate Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Patients With Bleeding Events (Major and Minor) [ Time Frame: From Screening until 30 days after first drug administration (end of trial visit) ]

    Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:

    Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds.


  • Number of Patients With Adverse Events [ Time Frame: From Screening until 30 days after first drug administration (end of trial visit) ]
    Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered "on-treatment" if occurring within 72 hours after last drug administration.

  • Plasma Concentration of Free Dabigatran [ Time Frame: 3 days ]
    Plasma concentration of free dabigatran measured at 72 hours after first dose

  • Plasma Concentration of Total Dabigatran [ Time Frame: Day 3 ]
    Plasma concentration of total dabigatran measured at 72 hours after first dose

  • Thrombin Time (TT) Centrally Measured [ Time Frame: Day 3 ]
    Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.

  • TT Locally Measured [ Time Frame: Day 3 ]
    Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.


Secondary Outcome Measures:
  • Activated Partial Thromboplastin Time (aPTT) Centrally Measured [ Time Frame: Day 3 ]
    Measurement of aPTT was performed locally and centrally using validated assays.

  • aPTT Locally Measured [ Time Frame: Day 3 ]
    Measurement of aPTT was performed locally and centrally using validated assays.

  • Ecarin Clotting Time (ECT) [ Time Frame: Day 3 ]
    Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.

  • Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs [ Time Frame: Baseline and 3 days ]
    Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.

  • Occurences of Clinical Outcome [ Time Frame: 3 days ]
    Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported.


Enrollment: 9
Study Start Date: June 2009
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dabigatran etexilate
open label; patient to receive dabigatran etexilate BID for three days
Drug: dabigatran etexilate
2.14 mg/kg BID to a max 150 mg BID

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. males or females 12 to less than 18 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

Exclusion criteria:

  1. weight less than 32 kg
  2. conditions associated with increased risk of bleeding
  3. severe renal dysfunction or requirement for dialysis
  4. active infective endocarditis
  5. hepatic disease
  6. pregnant females or females not using medically accepted contraceptive method
  7. anemia or thrombocytopenia
  8. use of prohibited or restricted drug within previous week
  9. received investigational drug within past 30 days
  10. unreliable patients or patients who have any condition that would not allow safe participation in study
  Contacts and Locations
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): NCT00844415


Locations
Canada, Alberta
1160.88.00002 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, Ontario
1160.88.00001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00844415     History of Changes
Other Study ID Numbers: 1160.88
First Submitted: February 13, 2009
First Posted: February 16, 2009
Results First Submitted: February 13, 2013
Results First Posted: March 26, 2013
Last Update Posted: June 9, 2014
Last Verified: December 2013

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