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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
First Posted : February 23, 2015
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: DW-3102 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Estimated Primary Completion Date : October 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. The change of LDL-C% [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02368613     History of Changes
Other Study ID Numbers: DW-3102_201
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases