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

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Primary Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: D377
* Drug: CKD-331
* Drug: D086
* Drug: Placebo (for D377)
* Drug: Placebo (for CKD-331)
* Drug: Placebo (for D086)


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-391<br>D377 + CKD-331 + placebo (for D086) | Drug: D377<br>* oral, once daily, 8 weeks<br>Drug: CKD-331<br>* oral, once daily, 8 weeks<br>Drug: Placebo (for D086)<br>* oral, once daily, 8 weeks<br>|
| Active Comparator: CKD-331<br>CKD-331 + placebo (for D377) + placebo (for D086) | Drug: CKD-331<br>* oral, once daily, 8 weeks<br>Drug: Placebo (for D377)<br>* oral, once daily, 8 weeks<br>Drug: Placebo (for D086)<br>* oral, once daily, 8 weeks<br>|
| Active Comparator: D377<br>D377 + placebo (for CKD-331) + placebo (for D086) | Drug: D377<br>* oral, once daily, 8 weeks<br>Drug: Placebo (for CKD-331)<br>* oral, once daily, 8 weeks<br>Drug: Placebo (for D086)<br>* oral, once daily, 8 weeks<br>|
| Active Comparator: D086<br>D086 + placebo (for D377) + placebo (for CKD-331) | Drug: D086<br>* oral, once daily, 8 weeks<br>Drug: Placebo (for D377)<br>* oral, once daily, 8 weeks<br>Drug: Placebo (for CKD-331)<br>* oral, once daily, 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change | from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C) | Baseline, Week 8 |