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Completed

NCT Number: NCT02170935

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

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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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIBR 1048 capsule

Drug

Primary outcomes

  1. maximum plasma concentration (Cmax)

    Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose

  2. time to maximum plasma concentration (Tmax)

    Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose

  3. total clearance of drug from plasma

    Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose

  4. terminal elimination constant

    Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose

  5. time of last measureable BIBR 953 ZW plasma concentration (Tf)

    Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose

  6. area under the plasma concentration time curve until Tf (AUC0-Tf)

    Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose

  7. area under the plasma concentration time extrapolated to infinity (AUC0-infinity)

    Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose

Secondary outcomes

  1. Occurrence of adverse events

    Time frame: up to 24 hours after drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2002
Primary completion
2002
First posted
Jun 23, 2014
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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