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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIBR 1048 capsule

Group Type EXPERIMENTAL

BIBR 1048 capsule

Intervention Type DRUG

Interventions

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BIBR 1048 capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No