Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
NCT ID: NCT00300430
Last Updated: 2009-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1911 participants
INTERVENTIONAL
2006-09-30
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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A
20 mg drug and ABT-335
ABT-335 and rosuvastatin calcium
ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
B
40 mg drug and ABT 335
ABT-335 and atorvastatin calcium
ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
C
40 mg drug and ABT-335
ABT-335 and simvastatin
ABT-335 135 mg plus simvastatin daily, 52 weeks
Interventions
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ABT-335 and rosuvastatin calcium
ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
ABT-335 and atorvastatin calcium
ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
ABT-335 and simvastatin
ABT-335 135 mg plus simvastatin daily, 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.
Exclusion Criteria
* Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Global Medical Information
North Chicago, Illinois, United States
Countries
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References
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Ferdinand KC, Davidson MH, Kelly MT, Setze CM. One-year efficacy and safety of rosuvastatin + fenofibric acid combination therapy in patients with mixed dyslipidemia: evaluation of dose response. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):117-25. doi: 10.2165/11597940-000000000-00000.
Jones PH, Bays HE, Davidson MH, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme. Clin Drug Investig. 2008;28(10):625-34. doi: 10.2165/00044011-200828100-00003.
Other Identifiers
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M05-758
Identifier Type: -
Identifier Source: org_study_id
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