A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia

Study Overview
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Brief Summary
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A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia

Official Title
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A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia

Conditions
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Hypertension, Dyslipidemias

Intervention / Treatment
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* Drug: HCP1701
* Drug: Losartan
* Drug: Amlodipine
* Drug: Rosuvastatin and Ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 19 Patients who understood the contents and purpose of this trial and signed informed consent form Patients with essential hypertension and dyslipidemia Exclusion Criteria: Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg Concomitant administration of cyclosporine Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin CPK normal range > 2 times Secondary hypertension and suspected secondary hypertension Orthostatic hypotension with symptoms Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times) Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times) Active gout or hyperuricemia(uric acid ≥ 9mg/dL) IDDM or uncontrolled type 2 diabetes mellitus (HbA1c > 9%) Ventricular arrhythmia Medical history Severe heart disease(heart failure of NYHA class III-IV) Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA) Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve Ischemic heart disease(myocardial infarction, angina) within 6months Angioplasty or coronary artery bypass graft(CABG) surgery within 6months

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: Experimental<br>HCP1701 | Drug: HCP1701<br>* HCP1701<br>|
| Active Comparator: Active Comparator 1<br>HGP0904, HGP0608 | Drug: Losartan<br>* Losartan<br>Drug: Amlodipine<br>* Amlodipine<br>|
| Active Comparator: Active Comparator 2<br>HGP0608, HCP1306 | Drug: Losartan<br>* Losartan<br>Drug: Rosuvastatin and Ezetimibe<br>* Rosuvastatin and Ezetimibe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in LDL-C (%) | Experimental, Active Control 1 | baseline, 8 weeks | 
| Change from baseline in sitting systolic blood pressure | Experimental, Active Control 2 | baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in LDL-C (%) | Experimental, Active Control 2 | baseline, 8 weeks | 
| Change from baseline in sitting systolic blood pressure | Experimental, Active Control 1 | baseline, 8 weeks | 
| Change from baseline in LDL-C (%) |  | baseline, 4 weeks | 
| Change from baseline in sitting systolic blood pressure |  | baseline, 4 weeks | 
| Change from baseline in TC, HDL-C, TG (%) |  | baseline, 4 weeks, 8 weeks | 
| Change from baseline in sitting distolic blood pressure |  | baseline, 4 weeks, 8 weeks | 
| Proportion of subject achieving LDL-C control |  | baseline, 4 weeks, 8 weeks | 
| Proportion of subjects achieving blood pressure control |  | baseline, 4 weeks, 8 weeks | 
| Proportion of responder for blood pressure |  | baseline, 4 weeks, 8 weeks | 
| Proportion of subject achieving both LDL-C and blood pressure control |  | baseline, 4 weeks, 8 weeks |