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

Phase 2

• Conditions: Hypercholesterolemia
• Interventions: Drug: DW-3102

• Registration Number: NCT02368613
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-15
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-23
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10
• Primary Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test1 group	DW-3102	DW-3102 125mg
placebo group	DW-3102	Placebo
test2 group	DW-3102	DW-3102 250mg
test3 group	DW-3102	DW-3102 500mg

Primary Outcome Measures

Name	Time	Method
The change of LDL-C%	6 weeks