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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

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

• 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