Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia

Study Overview
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Brief Summary
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This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia

Official Title
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Randomized, Multicenter, Parallel, Open, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension Patient With Dyslipidemia

Conditions
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Dyslipidemias, Hypertension

Intervention / Treatment
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* Drug: Rosuampin 10/5mg
* Drug: Rosuampin 20/5mg
* Drug: Amlodipine/Atorvastatin 5/20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both man and woman who is over 19 years old Patient with dyslipidemia and hypertension Written informed consent Exclusion Criteria: Triglyceride ≥ 400 mg/dL at screening Hypertensive patients who need antihypertensive medication except Amlodipine, β-blockers, RAS inhibitors sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg A history of rhabdomyolysis, myopathy Patient with hypersensitivity to Statin or Amlodipine Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease Creatine kinase (CK) level ≥ 5x ULN (upper limit of normal range) Contraindications stated in the Label of Rosuampin or Caduet Those participating in other clinical trials for investigational products at screening Patients deemed to be ineligible to participate in the trial by investigator

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: Rosuampin 10/5mg<br>Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks | Drug: Rosuampin 10/5mg<br>* Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks<br>|
| Experimental: Rosuampin 20/5mg<br>Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks | Drug: Rosuampin 20/5mg<br>* Rosuampin 20/5mg qd for 8 weeks<br>|
| Active Comparator: Amlodipine/Atorvastatin 5/20mg<br>Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks | Drug: Amlodipine/Atorvastatin 5/20mg<br>* Amlodipine/Atorvastatin 5/20mg qd for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change from baseline to week 8 in LDL-Cholesterol |  | Baseline/Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change from baseline to week 4 in LDL-Cholesterol |  | Baseline/Week 4 | 
| Proportion of subjects who reached the therapeutic goal to week 8 | * Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL | Week 8 | 
| Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C) | Total cholesterol, HDL-C, Triglyceride, Apo A-1, Apo B, Apo B/Apo A-1, Lipoprotein(a) | Baseline/Week 4, 8 | 
| Rate of change from baseline to week 4, 8 in hs-CRP |  | Baseline/Week 4, 8 | 
| Rate of change from baseline to week 4, 8 in glucose index | Fasting Blood Glucose, HbA1C, HOMA-IR | Baseline/Week 4, 8 | 
| Rate of change from baseline to week 4, 8 in msSBP & msDBP in both arm |  | Baseline/Week 4, 8 | 
| Rate of change from baseline to week 4, 8 in difference of msSBP & msDBP in both arm |  | Baseline/Week 4, 8 | 
| The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) |  | Week 8 |