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

NCT ID: NCT02368613

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo group

Placebo

Group Type: PLACEBO_COMPARATOR

DW-3102

Intervention Type: DRUG

test1 group

DW-3102 125mg

Group Type: ACTIVE_COMPARATOR

DW-3102

Intervention Type: DRUG

test2 group

DW-3102 250mg

Group Type: ACTIVE_COMPARATOR

DW-3102

Intervention Type: DRUG

test3 group

DW-3102 500mg

Group Type: ACTIVE_COMPARATOR

DW-3102

Intervention Type: DRUG

Interventions

DW-3102

Intervention Type: DRUG

Eligibility Criteria

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
• Patient who are inappropriate by investigator's decision

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DW-3102_201

Identifier Type: -

Identifier Source: org_study_id