Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: BIBR 1048 capsule Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2002
Actual Primary Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Experimental: BIBR 1048 capsule Drug: BIBR 1048 capsule



Primary Outcome Measures :
  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 Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: up to 24 hours after drug administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02170935     History of Changes
Other Study ID Numbers: 1160.30
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants