A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia

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

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.

Inclusion Criteria:

• Adults ≥ 19 years of age
• Primary hypercholesterolemia
• Patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator

Exclusion Criteria:

• Secondary hypercholesterolemia

• Conditions / situations such as:

  1. Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels
  2. Severe renal impairment or active liver disease

• History of hypersensitivity or allergies to investigational drugs or drug of similar chemical classes.

• History of drug abuse or alcoholism within 24 weeks before screening

• Any surgical or medical condition which might significantly affect the absorption, distribution, metabolism, or excretion of investigational drugs

• Patients who have been taken with other investigational drugs within 8 weeks before screening