A Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate adequate-dose of DW-3102 in the treatment of hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each groups are composed by 16, will be participated in this trial.

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: DW-3102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 19 years old Those who meet the fasting serum lipid levels along table Those who are under 350 mg/dL of TG level when fasting Exclusion Criteria: The patient of acute arterial disease The patient of severe heart failure(NYHA class III or IV) Within the last 6 months clinically meaningful treatment that requires that arrhythmias or cardiac conduction disorders Uncontrolled hypertension ( systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg or more later) Endocrine or metabolic disease patients known to affect serum lipids or lipoproteins Fibromyalgia, myopathy, rhabdomyolysis, or sudden muscle pain or have in the past, such as statin (HMG CoA reductase inhibitors) in patients with muscle -related adverse drug experience of the system Drug malabsorption by gastrointestinal surgery experience (but simple appendectomy and hernia surgery is excluded) or gastrointestinal disorders ( Crohn's disease , ulcers , acute or chronic pancreatitis , etc. ) Patients with history of malignancies including leukemia and lymphoma within the past five years If severe renal impairment or in patients with impaired liver and hematological findings following the same Patients who have participated in another clinical trial within the previous 30 days or Prior to the administration of at least five times the half-life of the active ingredient is not elapsed patient IND Those having a known hypersensitivity to hyperlipidemia treatment Patients with hypersensitivity or allergy to cruciferous plants Patients with a history of drug or alcohol abuse within the last 12 months Female patients of childbearing age In the case of male test subjects , if the spouse does not agree with the use of childbearing age when women work , recognized contraception exclusion criteria presented in Section 15 Patient who are inappropriate by 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>Placebo | Drug: DW-3102<br> <br> |
| Active Comparator: test1 group<br>DW-3102 125mg | Drug: DW-3102<br> <br> |
| Active Comparator: test2 group<br>DW-3102 250mg | Drug: DW-3102<br> <br> |
| Active Comparator: test3 group<br>DW-3102 500mg | Drug: DW-3102<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of LDL-C% |  | 6 weeks |