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

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ClinicalTrials.gov Identifier: NCT02170935
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE June 20, 2014
First Posted Date  ICMJE June 23, 2014
Last Update Posted Date June 23, 2014
Study Start Date  ICMJE April 2002
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
  • maximum plasma concentration (Cmax) [ Time Frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose ]
  • time to maximum plasma concentration (Tmax) [ Time Frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose ]
  • total clearance of drug from plasma [ Time Frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose ]
  • terminal elimination constant [ Time Frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
Occurrence of adverse events [ Time Frame: up to 24 hours after drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE Drug: BIBR 1048 capsule
Study Arms  ICMJE Experimental: BIBR 1048 capsule
Intervention: Drug: BIBR 1048 capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2014)
62
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02170935
Other Study ID Numbers  ICMJE 1160.30
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP