To Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety NVP-2203 in patients

Detailed Description
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This study is a multicenter, randomized, double-blind, parallel-group, phase 3 clinical trial to evaluate efficacy and safety of NVP-2203 in patients

Official Title
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A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: NVP-2203
* Drug: NVP-2203-R1
* Drug: NVP-2203-R2
* Drug: NVP-2203-R3
* Drug: NVP-2203 Placebo
* Drug: NVP-2203-R1 Placebo
* Drug: NVP-2203-R2 Placebo
* Drug: NVP-2203-R3 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 19 years of age Primary hypercholesterolemia Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: The subject not meet the specified LDL-C level Patients who were diagnosed with a malignant tumor within five years before Visit Inadequate subject for the clinical trial by the investigator's decision

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-2203<br>NVP-2203 Plus other Placebo for up to 8 weeks, oral dose | Drug: NVP-2203<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203-R1 Placebo<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203-R2 Placebo<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203-R3 Placebo<br>* Take it once daily for 8 weeks orally.<br>|
| Active Comparator: NVP-2203-R1<br>NVP-2203-R1 Plus other Placebo for up to 8 weeks, oral dose | Drug: NVP-2203-R1<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203 Placebo<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203-R2 Placebo<br>* Take it once daily for 8 weeks orally.<br>|
| Active Comparator: NVP-2203-R2<br>NVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose | Drug: NVP-2203-R2<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203 Placebo<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203-R1 Placebo<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203-R3 Placebo<br>* Take it once daily for 8 weeks orally.<br>|
| Active Comparator: NVP-2203-R3<br>NVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose | Drug: NVP-2203-R3<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203 Placebo<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203-R1 Placebo<br>* Take it once daily for 8 weeks orally.<br>Drug: NVP-2203-R2 Placebo<br>* Take it once daily for 8 weeks orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change in LDL-C level from baseline | change in LDL-C level | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change in lipid panel from baseline | change in lipid panel | Week 4, 8 |