Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets
Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets
To evaluate the efficacy and the safety of concomitant use of Ezetimibe/Rosuvastatin
 combination tablets and Candesartan cilexetil/Amlodipine besylate combination tablets
 compared to each combination tablet alone in patients with essential hypertension (HTN) and
 hyperlipidemia.
To improve the ease of use of high blood pressure and hyperlipidemia to improve patient
 compliance and reduce the risk of cardiovascular disease.

 And It is recommended to identify the need to develop a combination of Candesartan
 cilexetil/Amlodipine besylate combination tablets , and Ezetimibe/Rosuvastatin combination
 tablets.
[ Inclusion Criteria ]

 1. Adults aged 19 to <75 years.

 2. Diagnosed with essential HTN accompanied by hyperlipidemia (average siSBP ≥140 mmHg
 and LDL-C ≥100 mg/dL) or being treated for the condition after the diagnosis, at Visit
 1 (screening).

 3. Provided the signed informed consent form voluntarily after receiving explanation of
 the objectives, methods and effects of the study.

 4. Medically sterile or agreed to use medically acceptable contraceptive method during
 the study.

 [ Exclusion Criteria ]

 * Criteria Related to HTN and Dyslipidemia

 1. Severe HTN defined as average siDBP ≥110 mmHg or average siSBP ≥180 mmHg at Visit 1
 (screening).

 2. The difference in BPs between those measured at both arms at Visit 1 (screening) is
 ≥10 mmHg for siDBP or ≥20 mmHg for siSBP.

 3. LDL-C >250 mg/dL or TG ≥400 mg/dL at Visit 1 (screening).

 4. Diagnosed with or suspected of secondary HTN (e.g., renovascular disease, coarctation
 of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis,
 Cushing's syndrome, pheochromo-cytoma, polycystic kidney disease, etc.).

 5. Patients with symptomatic orthostatic HTN (difference in BPs between the value
 measured in supine position and the value measured in standing position is ≥20 mmHg
 for siSBP or ≥10 mmHg for siDBP).

 * Criteria Related to Medical History

 6. Diagnosis with type 1 diabetes mellitus (DM) or uncontrolled DM (patients on insulin
 therapy or patients with HbA1C ≥9%).

 7. Patients with severe heart disease - heart failure (NYHA Classes 3 and 4), history of
 ischemic cardiac disease (unstable angina, myocardial infarction), peripheral vascular
 diseases, percutaneous transluminal angioplasty, or coronary artery bypass graft
 within the recent 3 months.

 8. Patients with clinically significant ventricular tachycardia, atrial fibrillation,
 atrial flutter, or other clinically significant arrhythmia at the discretion of the
 investigator.

 9. History of muscular toxicity while on treatment with other HMG-CoA reductase
 inhibitors or fibrates.

 10. History of angioedema while on treatment with ACE inhibitors or ARBs.

 11. History of hypersensitivity to ARBs, dihydropyridines, or HMG-CoA reductase
 inhibitors.

 12. Patients with hypertrophic occlusive myocardiopathy, severe occlusive coronary artery
 disease, aortic stenosis, hemodynamically significant aortic, or mitral valve
 stenosis.

 13. Presence of severe cerebrovascular disorders (diagnosis of stroke, cerebral
 infarction, or cerebral hemorrhage within the recent 6 months).

 14. History or current evidence of wasting diseases, autoimmune diseases (such as
 rheumatoid arthritis and systemic lupus erythematosus), or connective tissue diseases.

 15. Known diagnosis of moderate or malignant retinopathy (including retinal hemorrhage,
 visual disturbance, and retinal microaneurysm within the recent 6 months).

 16. Patients with surgical or medical gastrointestinal diseases or having received surgery
 that could interfere with drug absorption, distribution, metabolism, and elimination
 and patients with active gastritis, gastrointestinal/rectal bleeding, or diagnosed
 with active inflammatory bowel disease within the recent 12 months.

 17. History of malignancy including leukemia and lymphoma within the recent 5 years
 (except for localized basal cell carcinoma of the skin).

 18. Patients with any inflammatory diseases requiring chronic anti-inflammatory therapy.

 19. Patients who received kidney transplant or with only one kidney.

 20. Presence of biliary obstruction or cholestasis.

 21. Presence of hereditary conditions such as galactose intolerance, Lapp lactase
 deficiency, or glucose-galactose malabsorption.

 22. Patients with shock.

 * Criteria Related to Clinical Laboratory Tests

 23. Laboratory abnormalities as follows:

 -  AST or ALT >3 x upper limit of normal (ULN);

 -  Serum creatinine >1.5 x ULN.

 24. History of myopathy or rhabdomyolysis (e.g., serum CK ≥5 x ULN).

 25. Uncontrolled abnormal thyroid function (e.g., TSH ≥1.5 x ULN).

 26. Persistent abnormal serum potassium level (e.g., serum potassium level <3.5 mmol/L or
 >5.5 mmol/L).

 27. Patients with conditions of body fluid depletion or laboratory findings indicating
 clinically significant electrolyte abnormality.

 * Others

 28. Needs for concomitant administration of non-study antihypertensive agents or
 prohibited medications during the study.

 29. Pregnant or lactating women.

 30. History of drug or alcohol abuse within the recent 1 year.

 31. Having received other investigational product within 4 weeks prior to screening.

 32. Patients considered ineligible for the study at the discretion of the principal
 investigator (PI) or study staff.