A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
NCT ID: NCT00491530
Last Updated: 2012-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
2007-06-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ABT-335 + rosuvastatin calcium
ABT-335
Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
rosuvastatin calcium
Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
ABT-335 + simvastatin
ABT-335
Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
simvastatin
Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
ABT-335 + atorvastatin calcium
ABT-335
Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
atorvastatin calcium
Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
Interventions
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ABT-335
Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
rosuvastatin calcium
Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
simvastatin
Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
atorvastatin calcium
Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has successfully completed the treatment phase of the preceding open-label year 1 study.
Exclusion Criteria
* Subject has prematurely discontinued his/her combination therapy administered in the preceding open-label year 1 study.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Locations
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Medical Information Specialist
Abbott Park, Illinois, United States
Countries
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References
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Kipnes MS, Roth EM, Rhyne JM, Setze CM, Lele A, Kelly MT, Sleep DJ, Stolzenbach JC. Year two assessment of fenofibric acid and moderate-dose statin combination: a phase 3, open-label, extension study. Clin Drug Investig. 2010;30(1):51-61. doi: 10.2165/11319800-000000000-00000.
Other Identifiers
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M06-884
Identifier Type: -
Identifier Source: org_study_id
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