Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
NCT ID: NCT00984113
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
44 participants
INTERVENTIONAL
2009-09-30
2009-12-31
Brief Summary
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Detailed Description
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* mild renal impairment: CrCl from 50 to ≤80 ml/min
* moderate renal impairment: CrCl from 30 to \<50 ml/min
* severe renal impairment: CrCl of \<30 ml/min
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A-Patients with mild renal impairment
Elinogrel
100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)
B-Healthy subjects matched to Group A
Elinogrel
100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)
C-Patients with moderate renal impairment
Elinogrel
100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)
D-Healthy subjects matched to Group C
Elinogrel
100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)
E-Patients with severe renal impairment
Elinogrel
100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)
F-Healthy subjects matched to Group E
Elinogrel
100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)
Interventions
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Elinogrel
100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects should have either normal renal function or have stable renal disease
Exclusion Criteria
* 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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Novartis
INDUSTRY
Portola Pharmaceuticals
INDUSTRY
Responsible Party
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Portola Pharmaceuticals, Inc.
Principal Investigators
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Matthew W McClure, MD
Role: STUDY_DIRECTOR
Portola Pharmaceuticals Inc.
Locations
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DaVita Clinical Research
Minneapolis, Minnesota, United States
NOCR-Knoxville
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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07-115 / CPRT128A2104
Identifier Type: -
Identifier Source: org_study_id
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