Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
NCT ID: NCT00300456
Last Updated: 2009-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
657 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
TRIPLE
Study Groups
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A
ABT-335 + 20 mg simvastatin
ABT-335
135 mg, daily, 12 weeks
Simvastatin
daily, 12 weeks, see Arm Description for dosage information
B
ABT-335 + 40 mg simvastatin
ABT-335
135 mg, daily, 12 weeks
Simvastatin
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 placebo information
D
20 mg simvastatin monotherapy
Simvastatin
daily, 12 weeks, see Arm Description for dosage information
Placebo
Daily, 12 weeks, see Arm Description for placebo information
E
40 mg simvastatin monotherapy
Simvastatin
daily, 12 weeks, see Arm Description for dosage information
Placebo
Daily, 12 weeks, see Arm Description for placebo information
F
80 mg simvastatin monotherapy
Simvastatin
daily, 12 weeks, see Arm Description for dosage information
Placebo
Daily, 12 weeks, see Arm Description for placebo information
Interventions
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ABT-335
135 mg, daily, 12 weeks
Simvastatin
daily, 12 weeks, see Arm Description for dosage information
Placebo
Daily, 12 weeks, see Arm Description for placebo information
Eligibility Criteria
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Inclusion Criteria
* Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.
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
Locations
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Global Medical Information
North Chicago, Illinois, United States
Countries
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References
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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, 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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M05-749
Identifier Type: -
Identifier Source: org_study_id
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