Clinical Efficacy and Safety Evaluation of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia

Study Overview
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Brief Summary
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A phase 3 study to evaluate efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia

Detailed Description
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This study is designed as a multi-center, double-blinded, randomized, phase 3 clinical trial to evaluate the efficacy and safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients with Hypertension and Dyslipidemia

Official Title
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Efficacy and Safety of Co-administered HGP0904, HGP0608 and HGP0816 in Patients With Hypertension and Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase 3 Study

Conditions
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Hypertension, Hyperlipidemia

Intervention / Treatment
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* Drug: HGP0904
* Drug: HGP0608
* Drug: HGP0816
* Drug: HGP0904 Placebo
* Drug: HGP0816 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 ≤ age ≤ 75 at Visit 1 1) BP: sitDBP ≥ 90mmHg 2) Cholesterol : LDL-C ≤ 250mg/dL, TG < 400mg/dL at Visit 2 : after TLC (after 4weeks) 1) BP: 80 mmHg ≤ sitDBP < 110mmHg 2) Cholesterol : following risk category (Cardiovascular Risk category) A : CHD risk factor 0 - 1, 160mg/dL ≤ LDL-C ≤ 250mg/dL B①: CHD risk factor≥2 and 10 year risk <10%, 160mg/dL ≤ LDL-C ≤ 250mg/dL B②: CHD risk factor≥2 and 10 year risk =10-20%, 130mg/dL ≤ LDL-C ≤ 250mg/dL C : CHD/CHD risk equivalents* or 10 year risk>20 ,100mg/dL ≤ LDL-C ≤ 250mg/dL 3) TG < 400mg/dL 4. Patients understood the contents and purpose of this trial and signed informed consent form Exclusion Criteria: At Visit 1, BP difference SBP ≥20mmHg or DBP ≥10mmHg Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA. reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin CPK normal range ≥ 3times Uncontrolled primary hypothyroidism(TSH normal range ≥ 2 times) Renal disease or suspected renal disease (Scr ≥ 2mg/dL, AST or ALT≥2 times) Active gout or hyperuricemia(at Visit 1, uric acid > 9mg/dL) IDDM or uncontrolled diabetes mellitus (HbA1c>9%) ventricular arrhythmia medical history severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertension encephalopathy, transient cerebral ischemic attack(TIA) severe heart disease(heart failure of NYHA class III-IV), valvular disease of heart or myocardial infarction and unstable angina angioplasty or coronary artery bypass graft(CABG) surgery within 6months

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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>HGP0904 + HGP0608 + HGP0816, once daily | Drug: HGP0904<br> <br> Drug: HGP0608<br> <br> Drug: HGP0816<br> <br> |
| Active Comparator: Active Comparator1<br>HGP0904 placebo + HGP0608 + HGP0816, once daily | Drug: HGP0608<br> <br> Drug: HGP0816<br> <br> Drug: HGP0904 Placebo<br> <br> |
| Active Comparator: Active Comparator2<br>HGP0904 + HGP0608 + HGP0816 placebo, once daily | Drug: HGP0904<br> <br> Drug: HGP0608<br> <br> Drug: HGP0816 Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in LDL-cholesterol at Week 8 |  | baseline and 8 weeks | 
| Change from baseline in sitDBP at Week 8 |  | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in LDL cholesterol at Week 4 |  | baseline and 4 weeks | 
| Percentage change from baseline in Total cholesterol, HDL cholesterol, Triglyceride at Week 4,8 |  | baseline, 4weeks and 8 weeks | 
| Change from baseline in sitDBP at Week 4 |  | baseline and 4weeks | 
| Change from baseline in sitSBP at week 4, 8 |  | baseline, 4weeks and 8 weeks | 
| Proportion of subjects achieving LDL-cholesterol goals by cardiovascular risk category at Week 4, 8 |  | baseline, 4weeks and 8 weeks | 
| Proportion of subjects achieving Blood Pressure control by cardiovascular risk category at Week 4, 8 |  | baseline, 4weeks and 8 weeks | 
| Proportion of subjects achieving LDL-cholesterol goals and Blood Pressure control by cardiovascular risk category at Week 4, 8 |  | baseline, 4weeks and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Hyperlipidemia