Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab

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 OLOMAX Tab (20/5/5mg, 20/5/10mg) in Hypertension Patients with Low-Intermediate Risk for Cardiovascular Disease.

Detailed Description
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The patients who meet the inclusion/exclusion criteria will be randomized 1:1:1 to test group 1 (olomax tablet 20/5/5mg), test group 2 (olomax tablet 20/5/10mg), and control group (sevica tablet 5/20mg. After randomization, the drug will be administered for 8 weeks according to the assigned group. During the administration period, subjects will conduct a total of three outpatient visits at 4 weeks (Visit 3) and 8 weeks (Visit 4, EOS), including randomized visits (Visit 2).

Official Title
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A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab in Hypertension Patients With Low-Intermediate Risk for Cardiovascular Disease

Conditions
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Hypertension, Dyslipidemias

Intervention / Treatment
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* Drug: OLOMAX 20/5/5mg
* Drug: OLOMAX 20/5/10mg
* Drug: Olmesartan 20 mg/Amlodipine 5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both man and woman who is over 19 years old Patients with hypertension Persons with mLDL ≥ 130mg/dL (low risk for cardiovascular disease) or mLDL ≥ 100mg/dL (intermediate risk for cardiovascular disease) Written informed consent Exclusion Criteria: Patient with hypersensitivity Olmesartan, Amlodipine, Rosuvastatin, dihydropyridine Who disagreed to perform effective contraception during the clinical trial Orthostatic hypotension with symptoms Secondary hypertension and suspected secondary hypertension Creatinine clearance < 30mL/min AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>OLOMAX 20/5/5mg | Drug: OLOMAX 20/5/5mg<br>* Tablets, Oral, QD<br>* Other names: Olomax Tablet;|
| Experimental: Treatment 2<br>OLOMAX 20/5/10mg | Drug: OLOMAX 20/5/10mg<br>* Tablets, Oral, QD<br>* Other names: Olomax Tablet;|
| Active Comparator: Treatment 3<br>Olmesartan 20 mg/Amlodipine 5 mg | Drug: Olmesartan 20 mg/Amlodipine 5 mg<br>* Tablets, Oral, QD<br>* Other names: Sevikar HCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in measured LDL-C (mLDL-C) | mLDL-C | After 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in measured LDL-C (mLDL-C) | mLDL-C | After 4 weeks | 
| Rate of change in cLDL-C | cLDL-C | After 4 weeks and 8 weeks | 
| Rate of change in lipid profile(without LDL-C) | Total cholesterol, HDL-C, Triglyceride, mLDL-C/HDL-C ratio, hs-CRP, Apo A-1, Apo B, Apo B/Apo A-1 ratio | After 4 weeks and 8 weeks | 
| Proportion of subjects who reached in mLDL-C < 70mg/dL | mLDL-C < 70mg/dL | After 4 weeks and 8 weeks | 
| Proportion of subjects who reached in mLDL-C < 100mg/dL | mLDL-C < 100mg/dL | After 4 weeks and 8 weeks | 
| Changes and rate of change in sitSBP | sitSBP | After 4 weeks and 8 weeks | 
| Changes and rate of change in sitDBP | sitDBP | After 4 weeks and 8 weeks | 
| Proportion of subjects who reached the therapeutic goal | sitSBP<140mmHg and sitDBP<90mmHg | After 8 weeks | 
| Changes and rate of change in glucose metabolic profile | Fasting plasma glucose (FPG), Fructosamine, HbA1c | After 4 weeks and 8 weeks |