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OpenTrials
Completed

NCT Number: NCT00844415

Safety and Tolerability of Dabigatran Etexilate in Adolescents

To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1160.88.00002 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males or females 12 to less than 18 years of age
  • objective diagnosis of primary VTE
  • completion of planned treatment course with LMWH or OAC for primary VTE
  • written informed consent by parent (legal guardian) and patient assent

Exclusion criteria

  • weight less than 32 kg
  • conditions associated with increased risk of bleeding
  • severe renal dysfunction or requirement for dialysis
  • active infective endocarditis
  • hepatic disease
  • pregnant females or females not using medically accepted contraceptive method
  • anemia or thrombocytopenia
  • use of prohibited or restricted drug within previous week
  • received investigational drug within past 30 days
  • unreliable patients or patients who have any condition that would not allow safe participation in study

Treatment and study plan

Dabigatran Etexilate

Drug

2.14 mg/kg BID to a max 150 mg BID

Primary outcomes

  1. 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.

  2. 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.

  3. Plasma Concentration of Free Dabigatran

    Time frame: 3 days

    Plasma concentration of free dabigatran measured at 72 hours after first dose

  4. Plasma Concentration of Total Dabigatran

    Time frame: Day 3

    Plasma concentration of total dabigatran measured at 72 hours after first dose

  5. Thrombin Time (TT) Centrally Measured

    Time frame: Day 3

    Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.

  6. TT Locally Measured

    Time frame: Day 3

    Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.

Secondary outcomes

  1. Activated Partial Thromboplastin Time (aPTT) Centrally Measured

    Time frame: Day 3

    Measurement of aPTT was performed locally and centrally using validated assays.

  2. aPTT Locally Measured

    Time frame: Day 3

    Measurement of aPTT was performed locally and centrally using validated assays.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
First posted
Feb 16, 2009
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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