This is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of CKD-391 and CKD-331 in patients with primary hypercholesterolemia
Participants were randomly assigned in a 1:1:1:1 ratio to the following groups: combination therapy of D377 and CKD-331, D377, CKD-331, and D086. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
228
Asan Medical Center
Seoul, South Korea
RECRUITINGPercent Change
from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, Week 8
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oral, once daily, 8 weeks
oral, once daily, 8 weeks
oral, once daily, 8 weeks