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

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/Amlodipine 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/Amlodipine in patients with primary hypercholesterolemia and essential hypertension. In Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine treatment group, 48 subjects will be assigned and the subjects administer Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine for 8 weeks. In Rosuvastatin/Ezetimibe +Telmisartan  treatment group, 48 subjects will be assigned and the subjects administer Rosuvastatin/Ezetimibe+Telmisartan for 8 weeks. In Telmisartan/Amlodipine treatment group, 48 subjects will be assigned and the subjects administer Telmisartan/Amlodipine for 8 weeks.

Official Title
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A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 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
* Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET


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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Co-administered of AD-2071 and AD-2073<br>48 subjects will be assigned and the subjects will be administered AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine) for 8 weeks. | Drug: Ezetimibe/Rosuvastatin<br>* PO, Once daily(QD), 8weeks<br>* Other names: Rosuvamibe Tab.;Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET<br>* PO, Once daily(QD), 8weeks<br>* Other names: Twynsta;|
| Active Comparator: Co-administered of AD-2071 and AD-2072<br>48 subjects will be assigned and the subjects will be administered AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(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: AD-2073<br>48 subjects will be assigned and the subjects will be administered AD-2073(Telmisartan/Amlodipine) for 8 weeks. | Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET<br>* PO, Once daily(QD), 8weeks<br>* Other names: Twynsta;|

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 AD-2071 + AD-2073 with AD-2073 | Baseline, Week 8 | 
| Mean sitting systolic blood pressure (MSSBP) | MSSBP change at Week 8 compared AD-2071 + AD-2072 with AD-2071 + AD-2073 | Baseline, Week 8 |