A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome
A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome
This is a Randomized, open-label, 2 groups, parallel design.
This study objective is to compare the safety and efficacy between fixed dose combination
 (Duowell® tab) and free pill combination therapy of Telmisartan and Rosuvastatin in
 hypertensive and hypercholesterolemic patients with metabolic syndrome.
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