Single dose safety and tolerability of dabigatran etexilate solution in children 1 to < 12 years of age

• Conditions: Venous Thrombotic Event; MedDRA version: 17.1Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-013618-29-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-27
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1) Males or females 1 to < 12 years of age
2) Objective diagnosis of VTE
3) End of planned treatment course with low molecular weight heparin (LMWH) or oral anticoagulant (OAC) for 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 (if applicable) at the time of ICF signature.
Are the trial subjects under 18? yes
Number of subjects for this age range: 16
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) conditions associated with increased risk of bleeding
2) renal dysfunction or requirement for dialysis
3) active infective endocarditis
4) hepatic disease
5) anemia or thrombocytopenia
6) use of prohibited or restricted drug within previous week
7) pregnant females or females not using medically accepted contraceptive method
8) received investigational drug within past 30 days
9) unreliable patients or patients who have any condition that would not allow safe participation in study
10) Weight less than 9 kg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified