A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
NCT ID: NCT00999336
Last Updated: 2023-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2009-07-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group H
Healthy subjects matched to the renal impairment groups
Betrixaban
80 mg betrixaban qd for 8 days
Group A
Patients with mild renal impairment
Betrixaban
80 mg betrixaban qd for 8 days
Group B
Patients with moderate renal impairment
Betrixaban
80 mg betrixaban qd for 8 days
Group C
Patients with severe renal impairment
Betrixaban
80 mg betrixaban qd for 8 days
Interventions
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Betrixaban
80 mg betrixaban qd for 8 days
Eligibility Criteria
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Inclusion Criteria
* Subjects should have either normal renal function or have stable renal disease
Exclusion Criteria
* Evidence of active bleeding or bleeding disorder
* Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
18 Years
80 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Portola Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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APEX GmbH
Munich, , Germany
Countries
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Other Identifiers
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08-016
Identifier Type: -
Identifier Source: org_study_id
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