Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.

A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia

The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
• Intervention / Treatment: Drug: ABT-335 and rosuvastatin calcium; Drug: ABT-335 and atorvastatin calcium; Drug: ABT-335 and simvastatin

• Study Type: Interventional
• Enrollment (Actual): 1911
• 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:

• Adult male and female subjects who voluntarily sign the informed consent.
• Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.

Exclusion Criteria:

• Subject is using or will use investigational medications, except as approved by Abbott.
• Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: A; 20 mg drug and ABT-335	Drug: ABT-335 and rosuvastatin calcium; ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks; Other Names: ABT-335; TRILIPIX
ACTIVE_COMPARATOR: B; 40 mg drug and ABT 335	Drug: ABT-335 and atorvastatin calcium; ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks; Other Names: ABT-335; TRILIPIX
ACTIVE_COMPARATOR: C; 40 mg drug and ABT-335	Drug: ABT-335 and simvastatin; ABT-335 135 mg plus simvastatin daily, 52 weeks; Other Names: ABT-335; TRILIPIX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study	Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study	Baseline to Week 52 of the open-label study
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study	Baseline to Week 52 of the open-label study
Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study	Baseline to Week 52 of the open-label study
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study	Baseline to Week 52 in this open-label study
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study	Baseline to Week 52 of the open-label study
Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study	Baseline to Week 52 of the open-label study
Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study	Baseline to Week 52 of the open-label study
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study	Baseline to Week 52 of the open-label study

Collaborators and Investigators

• Sponsor: Abbott

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (ACTUAL): March 1, 2008

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): July 23, 2009
• Last Update Submitted That Met QC Criteria: June 3, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• 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; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Atorvastatin; Rosuvastatin Calcium; Calcium; Calcium, Dietary; Simvastatin; Fenofibrate
• Other Study ID Numbers: M05-758