Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran

Criteria

Inclusion Criteria:

• Patients scheduled to undergo a primary elective total hip replacement

• Male or female being 18 years or older (women of child bearing potential may not be included)

• Patients weighing at least 40 kg

• Written informed consent for participation

Exclusion Criteria:

• Bleeding disorders, e.g. history of intracranial, intraocular, gastrointestinal or pulmonary bleeding, known thrombocytopenia, history of haemorrhagic stroke

• Known renal disease

• Known liver disease, alcohol or drug misuse

• Known malignancy

• Treatment with another study drug in the past month