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

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.

Study Overview

• Status: Unknown
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: DW-3102

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group; Placebo	Drug: DW-3102
Active Comparator: test1 group; DW-3102 125mg	Drug: DW-3102
Active Comparator: test2 group; DW-3102 250mg	Drug: DW-3102
Active Comparator: test3 group; DW-3102 500mg	Drug: DW-3102

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of LDL-C%	6 weeks

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Primary Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: February 15, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: DW-3102_201