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

Study Overview
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Brief Summary
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This is a Randomized, open-label, 2 groups, parallel design.

Detailed Description
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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.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Drug: Telmisartan 40mg + Rosuvastatin 20mg
* Drug: Telmisartan 80mg + Rosuvastatin 20mg
* Drug: Telmisartan 40mg, 80 mg
* Drug: Rosuvastatin 20mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan+Rosuvastatin<br>Duowell ® tablet (Telmisartan 40mg + Rosuvastatin 20mg) 1 tablet, once daily, Oral administration/ 8 weeks * But, the increased Duowell ® tablet (Telmisartan 80mg + Rosuvastatin 20mg) will get administrated orally one tablet once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit. | Drug: Telmisartan 40mg + Rosuvastatin 20mg<br> <br> * Other names: Duowell ® tablet;Drug: Telmisartan 80mg + Rosuvastatin 20mg<br> <br> * Other names: Duowell ® tablet;|
| Active Comparator: Telmisartan/Rosuvastatin<br>Telmisartan 40mg + Rosuvastatin 20mg 2 tablets, once daily, Oral administration/ 8 weeks * But, the increased Telmisartan 80mg + Rosuvastatin 20mg will get administrated orally 2 tablets once daily to the subjects who have mean systolic blood pressure more than 140mmHg based on arm, which was determined before, at 4week visit. | Drug: Telmisartan 40mg, 80 mg<br> <br> * Other names: Micardis tablet;Drug: Rosuvastatin 20mg<br> <br> * Other names: Monorova tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects that the mean Sitting Diastolic Blood Pressure(siSBP) and Low Density Lipoprotein-Cholesterol(LDL-C) level reach the treatment goals after 8 weeks from investigational product administration. |  | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Low Density Lipoprotein-Cholesterol(LDL-C) from baseline to 4 and 8 weeks |  | From baseline to 4 and 8 weeks | 
| Change of Sitting Systolic Blood Pressure(siSBP) and Sitting Diastolic Blood Pressure(siDBP) from baseline to 4 and 8 weeks |  | From baseline to 4 and 8 weeks | 
| The proportion of subjects that the mean sitting blood pressure(siBP) level reaches the treatment goals to 4 and 8 weeks |  | 4 and 8 weeks | 
| The proportion of subjects that the Low Density Lipoprotein-Cholesterol(LDL-C) level reaches treatment goals in accordance with guideline of National Cholesterol Education Program-Adult Treatment Panel(NCEP ATP) III to 4 and 8 weeks |  | 4 and 8 weeks | 
| Change of below indicators from baseline to 4 and 8 weeks |  | baseline to 4 and 8 weeks |