Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly
NCT ID: NCT00585143
Last Updated: 2012-09-28
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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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2008-01-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
ABT-335
45 mg once daily for 10 consecutive days
Rosuvastatin
10 mg once daily for 10 days
Interventions
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ABT-335
45 mg once daily for 10 consecutive days
Rosuvastatin
10 mg once daily for 10 days
Eligibility Criteria
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Inclusion Criteria
Either normal kidney function, or mild or moderate kidney impairment
Exclusion Criteria
History of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Torbjörn Lundström, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Site Reference ID/Investigator# 6610
Gainesville, Florida, United States
Site Reference ID/Investigator# 6738
Miami, Florida, United States
Site Reference ID/Investigator# 7723
Minneapolis, Minnesota, United States
Site Reference ID/Investigator# 7319
Knoxville, Tennessee, United States
Site Reference ID/Investigator# 6928
San Antonio, Texas, United States
Site Reference ID/Investigator# 8280
Richmond, Virginia, United States
Countries
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Other Identifiers
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M10-070
Identifier Type: -
Identifier Source: org_study_id