Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.

Detailed Description
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This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension. In Rosuvastatin/Ezetimibe+Telmisartan treatment group, 60 subjects will be assigned and the subjects administer Rosuvastatin/Ezetimibe+Telmisartan for 8 weeks. In Rosuvastatin/Ezetimibe treatment group, 60 subjects will be assigned and the subjects administer Rosuvastatin/Ezetimibe for 8 weeks. In Telmisartan treatment group, 60 subjects will be assigned and the subjects administer Telmisartan for 8 weeks.

Official Title
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A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan in Patients With Primary Hypercholesterolemia and Essential Hypertension

Conditions
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Hypercholesterolemia, Hypertension

Intervention / Treatment
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* Drug: Ezetimibe/Rosuvastatin
* Drug: Telmisartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Subjects with hypertension and hyperlipidemia Exclusion Criteria: Patient with known or suspected secondary hypertension Other exclusions applied

Ages Eligible for Study
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Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ezetimibe/Rosuvastatin and Telmisartan<br>60 subjects will be assigned and the subjects will be administered Ezetimibe/Rosuvastatin and Telmisartan for 8 weeks. | Drug: Ezetimibe/Rosuvastatin<br>* PO, Once daily(QD), 8weeks<br>* Other names: Rosuvamibe Tab.;Drug: Telmisartan<br>* PO, Once daily(QD), 8weeks<br>* Other names: Micardis Tab.;|
| Active Comparator: Ezetimibe/Rosuvastatin<br>60 subjects will be assigned and the subjects will be administered Ezetimibe/Rosuvastatin for 8 weeks. | Drug: Ezetimibe/Rosuvastatin<br>* PO, Once daily(QD), 8weeks<br>* Other names: Rosuvamibe Tab.;|
| Active Comparator: Telmisartan<br>60 subjects will be assigned and the subjects will be administered Telmisartan for 8 weeks. | Drug: Telmisartan<br>* PO, Once daily(QD), 8weeks<br>* Other names: Micardis Tab.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoprotein cholesterol (LDL-C) | LDL-C change at Week 8 compared to Baseline | Baseline, Week 8 | 
| Mean sitting systolic blood pressure (MSSBP) | MSSBP change at Week 8 compared to Baseline | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sitting systolic blood pressure (MSSBP) | MSSBP change at Week 4 compared to Baseline | Baseline, Week 4 | 
| Low density lipoprotein cholesterol (LDL-C) | LDL-C change at Week 4 compared to Baseline | Baseline, Week 4 | 
| Mean sitting diastolic blood pressure (MSDBP) | MSDBP change at Week 4, 8 compared to Baseline | Baseline, Week 4, Week 8 | 
| Total Cholesterol (TC) | TC change at Week 4, 8 compared to Baseline | Baseline, Week 4, Week 8 | 
| High density lipoprotein cholesterol (HDL-C) | HDL-C change at Week 4, 8 compared to Baseline | Baseline, Week 4, Week 8 | 
| Triglyceride (TG) | TG change at Week 4, 8 compared to Baseline | Baseline, Week 4, Week 8 | 
| Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C) | LDL-C/HDL-C change at Week 4, 8 compared to Baseline | Baseline, Week 4, Week 8 | 
| Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C) | TC/HDL-C change at Week 4,8 compared to Baseline | Baseline, Week 4, Week 8 |