A Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients
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ClinicalTrials.gov Identifier: NCT02368613
Recruitment Status : Unknown
Verified October 2016 by Daewon Pharmaceutical Co., Ltd.. Recruitment status was: Not yet recruiting
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.
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Ages Eligible for Study:
19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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