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

NCT02368613 | Unknown Phase 2

• 1 other identifier: DW-3102_201
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The change of LDL-C%

  6 weeks

Study Arms (4)

placebo group

PLACEBO COMPARATOR

Placebo

Drug: DW-3102

test1 group

ACTIVE COMPARATOR

DW-3102 125mg

Drug: DW-3102

test2 group

ACTIVE COMPARATOR

DW-3102 250mg

Drug: DW-3102

test3 group

ACTIVE COMPARATOR

DW-3102 500mg

Drug: DW-3102

Interventions

DW-3102 DRUG

placebo group; test1 group; test2 group; test3 group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2015
• First Posted: February 23, 2015
• Primary Completion: October 1, 2017
• Last Updated: October 10, 2016

Record last verified: 2016-10