Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood
AbbVie (prior sponsor, Abbott)
The primary purpose of this study is to test the effect and safety of once daily ABT-335 on
the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients
with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol
("bad cholesterol") after taking atorvastatin.
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
The primary purpose of this study is to compare the safety and efficacy of ABT-335
(investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin
coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.
ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study
Phase 1/Phase 2
The objectives of the study are:
1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT
(reverse cholesterol transport) in men and post-menopausal women diagnosed with
dyslipidemia (i.e., low high-density lipoprotein [HDL] cholesterol levels and elevated
triglyceride [TG] concentrations).
2. To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL.
3. To obtain pilot data for power calculations for subsequent comparative study.
Effect of Choline Fenofibrate (SLV348) on Macular Edema
The purpose of this study is to evaluate the effect of choline fenofibrate on the regression
of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with
diabetic macular edema (DME)
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