A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome

• Status: Terminated
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Randomized, open-label, 2 groups, parallel design.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Collaborator: Linical Korea
• Treatments: Rosuvastatin Calcium; Telmisartan

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