Clinical trial NCT00300456: Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin 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 ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin 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: 657
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) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.


Eligibility criteria: Inclusion Criteria:

* Subjects with mixed dyslipidemia
* Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.

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