Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
Intervention: ABT-335 and rosuvastatin calcium (Drug); ABT-335 and atorvastatin calcium (Drug); ABT-335 and simvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-Blind Studies or in This Open-Label Study
Secondary outcome: Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-Label StudyMean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From 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 Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From 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 Mean Percent Change in Total Cholesterol From 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 Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Week 52 of the Open-Label Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Global Medical Information, North Chicago, Illinois 60064, United States
Additional Information
Starting date: September 2006
Last updated: June 3, 2009
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