Safety and Tolerability of Dabigatran Etexilate in Adolescents

NCT00844415 | Completed Phase 2 Results

• 1 other identifier: 1160.88
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (6)

• Number of Patients With Bleeding Events (Major and Minor)

  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.

  From Screening until 30 days after first drug administration (end of trial visit)

• Number of Patients With Adverse Events

  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.

  From Screening until 30 days after first drug administration (end of trial visit)

• Plasma Concentration of Free Dabigatran

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

  3 days

• Plasma Concentration of Total Dabigatran

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

  Day 3

• Thrombin Time (TT) Centrally Measured

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

  Day 3

• TT Locally Measured

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

  Day 3

Secondary Outcomes (5)

• Activated Partial Thromboplastin Time (aPTT) Centrally Measured

  Day 3

• aPTT Locally Measured

  Day 3

• Ecarin Clotting Time (ECT)

  Day 3

• Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs

  Baseline and 3 days

• Occurences of Clinical Outcome

  3 days

Study Arms (1)

dabigatran etexilate

EXPERIMENTAL

open label; patient to receive dabigatran etexilate BID for three days

Drug: dabigatran etexilate

Interventions

dabigatran etexilate DRUG

2.14 mg/kg BID to a max 150 mg BID

dabigatran etexilate

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1160.88.00002 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1160.88.00001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

Related Publications (1)

• Halton JM, Lehr T, Cronin L, Lobmeyer MT, Haertter S, Belletrutti M, Mitchell LG. Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study. Thromb Haemost. 2016 Aug 30;116(3):461-71. doi: 10.1160/TH15-04-0275. Epub 2016 Jun 30.

  PMID: 27357738 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2012
• Last Updated: February 12, 2025
• Results First Posted: March 26, 2013

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)