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

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02368613
• Other study ID #: DW-3102_201
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 15, 2015
• Last updated: October 7, 2016

Study information

• Verified date: October 2016
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug SafetyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• DW-3102

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of LDL-C%		6 weeks	No