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

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BIBR 1048 capsule
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BIBR 1048 capsule

    Arm Description

    Outcomes

    Primary Outcome Measures

    maximum plasma concentration (Cmax)
    time to maximum plasma concentration (Tmax)
    total clearance of drug from plasma
    terminal elimination constant
    time of last measureable BIBR 953 ZW plasma concentration (Tf)
    area under the plasma concentration time curve until Tf (AUC0-Tf)
    area under the plasma concentration time extrapolated to infinity (AUC0-infinity)

    Secondary Outcome Measures

    Occurrence of adverse events

    Full Information

    First Posted
    June 20, 2014
    Last Updated
    June 20, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02170935
    Brief Title
    Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    June 2002 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Thromboembolism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BIBR 1048 capsule
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    BIBR 1048 capsule
    Primary Outcome Measure Information:
    Title
    maximum plasma concentration (Cmax)
    Time Frame
    pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
    Title
    time to maximum plasma concentration (Tmax)
    Time Frame
    pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
    Title
    total clearance of drug from plasma
    Time Frame
    pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
    Title
    terminal elimination constant
    Time Frame
    pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
    Title
    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
    Title
    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
    Title
    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 Outcome Measure Information:
    Title
    Occurrence of adverse events
    Time Frame
    up to 24 hours after drug administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.30_U03-1309-01.pdf
    Description
    Related Info

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

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