Safety and tolerability of dabigatran etexilate in adolescents

Conditions: Venous Thrombotic Event
MedDRA version: 14.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2008-006866-27-Outside-EU/EEA

Lead Sponsor: Boehringer Ingelheim (Canada) Ltd./Ltée

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 8

Inclusion Criteria

1) Males or females 12 to <18 years of age
2) Objective diagnosis of primary VTE
3) Completion of planned treatment course with low molecular weight heparin (LMWH) or
oral anticoagulant (OAC) for primary VTE with INR and aPTT both within normal limits
4) Written informed consent provided by the patient’s parent (or legal guardian) and assent
provided by the patient at the time of ICF signature.
Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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,<br>2) Incidence of all adverse events,<br>3) Pharmacodynamic parameters: central and local measurement of TT,<br>4) Pharmacokinetic parameters: plasma concentrations of total and free dabigatran, BIBR 1048 BS, BIBR 951BS, and BIBR 1087 SE.<br>;Timepoint(s) of evaluation of this end point: Endpoints 1) & 2) measured during screening, treatment period and 30 day followup.<br>Endpoints 3) & 4) measured during screening (baseline) and treatment period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Changes in laboratory and clinical parameters such as liver enzymes, ECG, and physical<br>examination,<br>2) Occurrences of clinical outcomes including recurrent thrombosis, post thrombotic<br>syndrome (PTS), pulmonary emboli (PEs), and total and venous thrombolic event (VTE)<br>related mortality objectively assessed for example by ultrasound, venography or<br>computed chromatography (CT) scan (based on the thrombus location).<br>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.<br>Endpoint 3) measured during screening (baseline) and treatment period.