Dyslipidemia Clinical Trial
Official title:
ABT-335 (Choline Fenofibrate)Reverse Cholesterol Transport (RCT) Study
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.
This trial assesses the effects of ABT-335 on RCT as measured by cholesterol efflux or rate
of appearance of cholesterol (Ra in mg/kg/hr), cholesterol excretion (%/day), RCT efflux
(mg/kg/day) and de novo cholesterol synthesis (%) during a baseline period (7 days) and
during a treatment period (94 days).
The goal of using RCT to reverse atherosclerosis is to increase the rate of cholesterol
export or "efflux" from the tissues and plaques. An increase in this cholesterol efflux rate
should shrink arterial plaques by decreasing their static accumulation of cholesterol. While
some currently marketed drugs have a positive impact on RCT by increasing the rate of
cholesterol excretion from the body, no drug has yet been approved to increase the rate of
cholesterol efflux from the tissues
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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