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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: BIBR 1048 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170935

1160.30

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

BIBR 1048 capsule

Experimental group

Treatment:

Drug: BIBR 1048 capsule