Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood
NCT ID: NCT00300482
Last Updated: 2009-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1445 participants
INTERVENTIONAL
2006-03-31
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
QUADRUPLE
Study Groups
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A
ABT-335 + 10 mg rosuvastatin
ABT-335
135 mg, daily, 12 weeks
Rosuvastatin Calcium
Daily, 12 weeks, see Arm Description for dosage information
B
ABT-335 + 20 mg rosuvastatin
ABT-335
135 mg, daily, 12 weeks
Rosuvastatin Calcium
Daily, 12 weeks, see Arm Description for dosage information
C
ABT-335 monotherapy
ABT-335
135 mg, daily, 12 weeks
Placebo
Daily, 12 weeks, see Arm Description for information regarding placebo type
D
10 mg rosuvastatin monotherapy
Rosuvastatin Calcium
Daily, 12 weeks, see Arm Description for dosage information
Placebo
Daily, 12 weeks, see Arm Description for information regarding placebo type
E
20 mg rosuvastatin monotherapy
Rosuvastatin Calcium
Daily, 12 weeks, see Arm Description for dosage information
Placebo
Daily, 12 weeks, see Arm Description for information regarding placebo type
F
40 mg rosuvastatin monotherapy
Rosuvastatin Calcium
Daily, 12 weeks, see Arm Description for dosage information
Placebo
Daily, 12 weeks, see Arm Description for information regarding placebo type
Interventions
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ABT-335
135 mg, daily, 12 weeks
Rosuvastatin Calcium
Daily, 12 weeks, see Arm Description for dosage information
Placebo
Daily, 12 weeks, see Arm Description for information regarding placebo type
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who are taking certain medications or unstable dose of specific medications.
* Women who are pregnant or plan on becoming pregnant or women who are lactating.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Maureen Kelly, MD
Role: PRINCIPAL_INVESTIGATOR
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.
Rosenson RS, Carlson DM, Kelly MT, Setze CM, Hirshberg B, Stolzenbach JC, Williams LA. Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. Cardiovasc Drugs Ther. 2011 Feb;25(1):47-57. doi: 10.1007/s10557-010-6273-5.
Bays HE, Roth EM, McKenney JM, Kelly MT, Thakker KM, Setze CM, Obermeyer K, Sleep DJ. The effects of fenofibric acid alone and with statins on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia. Diabetes Care. 2010 Sep;33(9):2113-6. doi: 10.2337/dc10-0357. Epub 2010 Jun 23.
Jones PH, Cusi K, Davidson MH, Kelly MT, Setze CM, Thakker K, Sleep DJ, Stolzenbach JC. Efficacy and safety of fenofibric acid co-administered with low- or moderate-dose statin in patients with mixed dyslipidemia and type 2 diabetes mellitus: results of a pooled subgroup analysis from three randomized, controlled, double-blind trials. Am J Cardiovasc Drugs. 2010;10(2):73-84. doi: 10.2165/10061630-000000000-00000.
Jones PH, Davidson MH, Kashyap ML, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis. 2009 May;204(1):208-15. doi: 10.1016/j.atherosclerosis.2008.09.027. Epub 2008 Oct 5.
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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M05-748
Identifier Type: -
Identifier Source: org_study_id
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