Hypercholesterolemia
Conditions
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.
Interventions
DRUGDW-3102
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of LDL-C% | 6 weeks |
Outcome results
None listed