Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
• Intervention / Treatment: Drug: ABT-335; Drug: Atorvastatin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 613
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • North Chicago, Illinois, United States, 60064
      • Global Medical Information

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with mixed dyslipidemia
• Subjects must 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: A; ABT-335 + 20 mg atorvastatin	Drug: ABT-335; 135 mg, daily, 12 weeks; Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information
ACTIVE_COMPARATOR: B; ABT-335 + 40 mg atorvastatin	Drug: ABT-335; 135 mg, daily, 12 weeks; Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information
PLACEBO_COMPARATOR: C; ABT-335 monotherapy	Drug: ABT-335; 135 mg, daily, 12 weeks; Drug: Placebo; daily, 12 weeks, see Arm Description for placebo information
PLACEBO_COMPARATOR: D; 20 mg atorvastatin monotherapy	Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information; Drug: Placebo; daily, 12 weeks, see Arm Description for placebo information
PLACEBO_COMPARATOR: E; 40 mg atorvastatin monotherapy	Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information; Drug: Placebo; daily, 12 weeks, see Arm Description for placebo information
PLACEBO_COMPARATOR: F; 80 mg atorvastatin monotherapy	Drug: Atorvastatin; Daily, 12 weeks, see Arm Description for dosage information; Drug: Placebo; daily, 12 weeks, see Arm Description for placebo information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in Triglycerides From Baseline to Final Visit	[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100	Baseline to 12 Weeks (Final Visit)
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit	[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100	Baseline to 12 Weeks (Final Visit)
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit	[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100	Baseline to 12 Weeks (Final Visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit	[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100	Baseline to 12 Weeks (Final Visit)
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit	[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100	Baseline to 12 Weeks (Final Visit)
Mean Percent Change in Total Cholesterol From Baseline to Final Visit	[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100	Baseline to 12 Weeks (Final Visit)
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit	[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100	Baseline to 12 Weeks (Final Visit)
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit	[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100	Baseline to 12 Weeks (Final Visit)

Collaborators and Investigators

• Sponsor: Abbott

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (ACTUAL): February 1, 2007

Study Registration Dates

• First Submitted: March 7, 2006
• First Submitted That Met QC Criteria: March 7, 2006
• First Posted (ESTIMATE): March 9, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2009
• Last Update Submitted That Met QC Criteria: June 1, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: M05-750