Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT02968160
Eligibility Criteria:
Inclusion Criteria:
* Aged between 19 and 79 years old at screening visit
* Subjects who have being used anti-hypertension drugs and Lipid lowering agents over 4weeks before randomization.
* Subjects who have been diagnosed with metabolic syndrome according to following criteria Definition of patients with metabolic syndrome: Patients satisfy two of the following criteria at least
* Abdominal obesity: Waist measurement \> 90 cm(male), \> 80 cm(female)
* Triglyceride(TG) ≥ 150 mg/dL(
* High-Density Lipoprotein Cholesterol(HDL-C) \< 40 mg/dL(male), \< 50 mg/dL (female)
* Fasting Plasma Glucose(FPG) ≥ 100 mg/dL or Subject who has being used oral hypoglycemic agents
* Childbearing potential women have certainly negative of the pregnancy test at screening visit (visit 1), and agree to implement the effective contraception during the study period(including the medically non-pregnant state)
* Subjects who have signed after fully understanding the purpose, content, characteristics and risk of the investigational product and get explained enough.
Exclusion Criteria:
* Subjects who taking anti-hypertension drugs more than three agent
* Subjects who have mean Sitting Systolic Blood Pressure(siSBP) \> 160 mmHg (excluded if appliable, one of the arms)
* Subjects who have blood pressure ≥ 140/90 mmHg with taking 2 or more anti-hypertension drugs (except if any of the arms)
* Subjects that Low Density Lipoprotein-Cholesterol(LDL-C) isn't properly controlled according to National Cholesterol Education Program Adults Treatment Panel (NCEP ATP) III criteria
* Subjects who have triglyceride (TG) ≥ 400mg/dL
* Subjects who have a difference more than 20mmHg at the mean Sitting Diastolic Blood Pressure(siSBP) measured three times in both arms.
* Other exclusions applied
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
79 Years
Study:
NCT02968160
Study Brief:
Protocol Section:
NCT02968160