NCT02170935

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

June 20, 2014

Last Update Submit

June 20, 2014

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (7)

  • maximum plasma concentration (Cmax)

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

  • time to maximum plasma concentration (Tmax)

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

  • total clearance of drug from plasma

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

  • terminal elimination constant

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

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

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

  • 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

  • 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

Secondary Outcomes (1)

  • Occurrence of adverse events

    up to 24 hours after drug administration

Study Arms (1)

BIBR 1048 capsule

EXPERIMENTAL
Drug: BIBR 1048 capsule

Interventions

BIBR 1048 capsuleDRUG
BIBR 1048 capsule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 23, 2014

Study Start

April 1, 2002

Primary Completion

June 1, 2002

Last Updated

June 23, 2014

Record last verified: 2014-06