Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran

Criteria

Inclusion criteria:

1. males or females 1 to less than 12 years of age

2. objective diagnosis of primary VTE

3. completion of planned treatment course with LMWH or OAC for primary VTE

4. written informed consent by parent (legal guardian) and patient assent (if applicable)

Exclusion criteria:

1. weight less than 9 kg

2. conditions associated with increased risk of bleeding

3. patients who have any condition that would not allow safe participation in study Note:

Further exclusion criteria apply