Clinical trial NCT00300430: Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
Official title: A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Coronary Heart Disease
Mixed Dyslipidemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-03-09
Enrollment: 1911
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
timeFrame: 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 outcomes:
measure: Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study
timeFrame: Baseline to Week 52 of the open-label study
measure: Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study
timeFrame: Baseline to Week 52 of the open-label study
measure: Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study
timeFrame: Baseline to Week 52 of the open-label study
measure: Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study
timeFrame: Baseline to Week 52 in this open-label study
measure: Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study
timeFrame: Baseline to Week 52 of the open-label study
measure: Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study
timeFrame: Baseline to Week 52 of the open-label study
measure: Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study
timeFrame: Baseline to Week 52 of the open-label study
measure: Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study
timeFrame: Baseline to Week 52 of the open-label study
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Global Medical Information
state: Illinois
Study officials:
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: 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.