Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.
Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/\< 1 drink per day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
atorvastatin 20 mg tablets, daily dosing, for 8 weeks.
2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
Linda Murray, DO - Radiant Research
Pinellas Park, Florida, United States
Sheila Rodstein, MD
Edina, Minnesota, United States
Dennis McCluskey, MD - Radiant Research
Mogadore, Ohio, United States
Michele Reynolds, MD
Dallas, Texas, United States
Percent Change in LDL-C After 8 Weeks of Therapy
Time frame: Baseline and 8 weeks of treatment
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Time frame: Baseline and 4 weeks
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William Jennings, MD - Radiant Research
San Antonio, Texas, United States