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

Venous Thromboembolism Clinical Trial

Official title:

Multicenter, Open-label-study to Assess PK Profile of a Single Oral Dose of 150 mg BIBR 1048 (Capsule) in Patients Shortly After Primary Elective Total Hip Replacement Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170935
• Other study ID #: 1160.30
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2014
• Last updated: June 20, 2014
• Start date: April 2002

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• BIBR 1048 capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum plasma concentration (Cmax)		pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose	No
Primary	time to maximum plasma concentration (Tmax)		pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose	No
Primary	total clearance of drug from plasma		pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose	No
Primary	terminal elimination constant		pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose	No
Primary	time of last measureable BIBR 953 ZW plasma concentration (Tf)		pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose	No
Primary	area under the plasma concentration time curve until Tf (AUC0-Tf)		pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose	No
Primary	area under the plasma concentration time extrapolated to infinity (AUC0-infinity)		pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose	No
Secondary	Occurrence of adverse events		up to 24 hours after drug administration	No

External Links

•   Link