A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
180mg, tablet, once daily, for 52 weeks
Rinku General Medical Center
Izumisano, Japan
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: From baseline to week 52
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Time frame: Baseline, week52
Percent Change in Non-HDL Cholesterol From Baseline to Week 52
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Time frame: Baseline, week52
Percent Change in Total Cholesterol From Baseline to Week 52
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Time frame: Baseline, week52
Percent Change in Apolipoprotein B From Baseline to Week 52
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Time frame: Baseline, week52
Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 52
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Time frame: Baseline, week52
Percent Change in Hemoglobin A1c From Baseline to Week 52
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
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Time frame: Baseline, week52
Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 52
The proportion of subjects whose LDL-C value achieves the lipid management goal at Week 52.
Time frame: Baseline, week52