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

Daewon Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: DW-3102

Study type: Interventional

Funder types: Industry

Identifiers

NCT02368613

DW-3102_201

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 4 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: DW-3102

test1 group

Active Comparator group

Description:

DW-3102 125mg

Treatment:

Drug: DW-3102

test2 group

Active Comparator group

Description:

DW-3102 250mg

Treatment:

Drug: DW-3102

test3 group

Active Comparator group

Description:

DW-3102 500mg

Treatment:

Drug: DW-3102