A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

A Year 2, Long-Term, Open-Label, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Abbott Park, Illinois, United States, 60064
      • Medical Information Specialist

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 the treatment phase of the preceding open-label year 1 study.

Exclusion Criteria:

• Subject is using or will use investigational medications, except as approved by Abbott.
• Subject has prematurely discontinued his/her combination therapy administered in the preceding open-label year 1 study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABT-335 + rosuvastatin calcium	Drug: ABT-335; Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study; Other Names: fenofibric acid; Drug: rosuvastatin calcium; Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study; Other Names: Crestor
Experimental: ABT-335 + simvastatin	Drug: ABT-335; Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study; Other Names: fenofibric acid; Drug: simvastatin; Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study; Other Names: Zocor
Experimental: ABT-335 + atorvastatin calcium	Drug: ABT-335; Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study; Other Names: fenofibric acid; Drug: atorvastatin calcium; Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study; Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study	All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.	Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 triglycerides minus baseline triglycerides)/baseline triglycerides] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 HDL-C minus baseline HDL-C)/baseline HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 LDL-C minus baseline LDL-C)/baseline LDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 Non-HDL-C minus baseline Non-HDL-C)/baseline Non-HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 Total-C minus baseline Total-C)/baseline Total-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)

Collaborators and Investigators

• Sponsor: Abbott

Publications and helpful links

General Publications

• Kipnes MS, Roth EM, Rhyne JM, Setze CM, Lele A, Kelly MT, Sleep DJ, Stolzenbach JC. Year two assessment of fenofibric acid and moderate-dose statin combination: a phase 3, open-label, extension study. Clin Drug Investig. 2010;30(1):51-61. doi: 10.2165/11319800-000000000-00000.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: June 22, 2007
• First Submitted That Met QC Criteria: June 25, 2007
• First Posted (Estimate): June 26, 2007

Study Record Updates

• Last Update Posted (Estimate): January 20, 2012
• Last Update Submitted That Met QC Criteria: January 18, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; 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; Fenofibric acid
• Other Study ID Numbers: M06-884