Back to resultsA Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients
Primary Purpose
Hypercholesterolemia
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
DW-3102
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
placebo group
test1 group
test2 group
test3 group
Arm Description
Placebo
DW-3102 125mg
DW-3102 250mg
DW-3102 500mg
Outcomes
Primary Outcome Measures
The change of LDL-C%
Secondary Outcome Measures
Full Information
NCT ID
NCT02368613
First Posted
February 15, 2015
Last Updated
October 7, 2016
Sponsor
Daewon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02368613
Brief Title
A Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
test1 group
Arm Type
Active Comparator
Arm Description
DW-3102 125mg
Arm Title
test2 group
Arm Type
Active Comparator
Arm Description
DW-3102 250mg
Arm Title
test3 group
Arm Type
Active Comparator
Arm Description
DW-3102 500mg
Intervention Type
Drug
Intervention Name(s)
DW-3102
Primary Outcome Measure Information:
Title
The change of LDL-C%
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients
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