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Safety and tolerability of dabigatran etexilate in adolescents

Open-label safety and tolerability study of dabigatran etexilate given for 3 days at the end of standard anticoagulant therapy in children aged 12 years to less than 18 years

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006866-27-Outside-EU/EEA
Enrollment
8
Registered
2012-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thrombotic Event MedDRA version: 14.1 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: dabigatran etexilate Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: dabigatran etexilate CAS Number: n.a. Current Sponsor code: BIBR 1048 MS Other des

Sponsors

Boehringer Ingelheim (Canada) Ltd./Ltée
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males or females 12 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Weight less than 32 kg 2)Conditions associated with an increased risk of bleeding 3) Severe renal dysfunction 4) Active infective endocarditis 5) Hepatic disease 6) pregnant females or females not using medically accepted contraceptive method 7) Anaemia or thrombocytopenia 8) use of prohibited or restricted drug within previous week 9) received investigational drug within past 30 days

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate tolerability and safety of dabigatran etexilate capsules in adolescents;Secondary Objective: none;Primary end point(s): 1) Incidence of all bleeding events, 2) Incidence of all adverse events, 3) Pharmacodynamic parameters: central and local measurement of TT, 4) Pharmacokinetic parameters: plasma concentrations of total and free dabigatran, BIBR 1048 BS, BIBR 951BS, and BIBR 1087 SE. ;Timepoint(s) of evaluation of this end point: Endpoints 1) & 2) measured during screening, treatment period and 30 day followup. Endpoints 3) & 4) measured during screening (baseline) and treatment period.—

Secondary

MeasureTime frame
Secondary end point(s): 1) Changes in laboratory and clinical parameters such as liver enzymes, ECG, and physical examination, 2) Occurrences of clinical outcomes including recurrent thrombosis, post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and venous thrombolic event (VTE) related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). 3) pharmacodynamic parameters: central and local measurement of aPTT and ECT;Timepoint(s) of evaluation of this end point: Endpoints 1) and 2) measured during screening, treatment period and 30 day followup. Endpoint 3) measured during screening (baseline) and treatment period.—

Countries

Canada

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com+18002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026