Clinical trial NCT00300482: Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood
Official title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Coronary Heart Disease
Mixed Dyslipidemia
Keywords: Dyslipidemia
Coronary Heart Disease
Mixed Dyslipidemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-03-09
Enrollment: 1445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.


Eligibility criteria: Inclusion Criteria:

* Patients with mixed dyslipidemia

Exclusion Criteria:

* Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
* 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.

Primary outcomes:
measure: Mean Percent Change in Triglycerides From Baseline to Final Visit
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
timeFrame: Baseline to 12 Weeks
Secondary outcomes:
measure: Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change in Total Cholesterol From Baseline to Final Visit
timeFrame: Baseline to 12 Weeks
measure: Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
timeFrame: Baseline to 12 Weeks
measure: Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
timeFrame: Baseline to 12 Weeks
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Global Medical Information
state: Illinois
Study officials:
affiliation: Abbott
name: Maureen Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.