A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Rosuvastatin in Comparison to Each Component Administered Alone in Patients With Essential Hypertension and Dyslipidemia
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Rosuvastatin in Comparison to Each Component Administered Alone in Patients With Essential Hypertension and Dyslipidemia
The purpose of this study is to evaluate the efficacy and safety of combination of
 Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with
 essential hypertension and dyslipidemia.
Inclusion Criteria:

 1. Patients who voluntarily signed informed consent for participating in this clinical
 trial

 2. Male and female between 20 and 75 years old

 3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening
 visit (Visit1)

 4. Patients who meet the following criteria of fasting LDL-C and blood pressure at
 Baseline visit (Visit3) assessment after undergoing the therapeutic lifestyle change.

 -  Low risk group: the case that does not have any other risk factor apart from
 hypertension / LDL-C (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, <180

 -  Moderate risk group: the case that has more than or equal to one risk factor
 apart from hypertension and has the 10-year risk of less than 10% / LDL-C
 (mg/dL): ≥160, ≤250, Mean SiSBP(mmHg): ≥140, <180

 -  Moderate high risk group: the case that has more than or equal to one risk factor
 apart from hypertension and has the 10-year risk between 10% and 20% / LDL-C
 (mg/dL): ≥130, ≤250, Mean SiSBP(mmHg): ≥140, <180

 -  High risk group: the case of CHD (Coronary heart disease) or CHD risk equivalents

 -  Risk factors include cigarette smoking, hypertension (BP≥140/90 mmHg or on
 antihypertensive medication), low HDL cholesterol (<40mg/dL), family history
 of premature CHD(CHD in male first-degree relative <55 years of age; CHD in
 female first-degree relative < 65 years of age), and age (men≥45 years;
 women ≥55 years). in case of HDL-C ≥60mg/dL, reduce 1 from the total number
 of risk factors.

 -  Electronic 10 year risk calculators are available at
 www.nhlbi.nih.gov/guidelines/cholesterol

 -  CHD includes history of myocardial infarction, unstable angina, coronary
 artery procedures (angioplasty or bypass surgery), or evidence of clinically
 significant myocardial ischemia.

 -  CHD risk equivalents include atherosclerotic disease (peripheral arterial
 disease, abdominal aortic aneurysm and carotid artery disease [transient
 ischemic attacks or stroke of carotid origin or >50% obstruction of a
 carotid artery]), diabetes and 2+ risk factors with 10 year risk of over 20%

 5. Subject must be able to understand the trial procedures and be willing to cooperate
 and complete the trial.

 Exclusion Criteria:

 1. Severe hypertension patients with mean siSBP ≥ 180mmHg and/or SiDBP ≥110mmHg at the
 assessment of Screening visit (Visit1) and/or Baseline visit (Visit3). Or patients
 with postural hypotension with manifestation.

 2. Patients with the mean SiSBP from 3 times of measurement of over 20mmHg.

 3. Secondary hypertension patients, but not limited to the following disease (example:
 renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of
 the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis,
 Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc)

 4. Secondary dyslipidemia: nephrotic syndrome, dysproteinemia, obstructive hepatopathy or
 Cushing's syndrome.

 5. Patients with fasting TG ≥ 400mg/dL at Pre-Baseline visit (Visit2) assessment

 6. History of myopathy, rhabdomyolysis or/and CK ≥ 2 times upper normal limit.

 7. Use of lipid modifying drug within 4 weeks prior to Pre-Baseline visit (Visit2) and/or
 antihypertensive drug within 2 weeks prior to Pre-Baseline visit(Visit2)

 8. Clinically significant renal function abnormality in the laboratory results at
 Pre-Baseline visit (i.e. serum creatinine ≥ 1.5 times upper normal limit), liver
 function abnormality (ALT, AST ≥ 2 times upper normal limit), severe fatty liver
 disease that requires medication.

 9. Clinically significant hypokalemia(less than 3.5 mmol/L) or hyperkalemia (exceeded 5.5
 mmol/L) measured at Pre-Baseline visit (Visit2)

 10. Subjects with following surgical and internal disease that may affect absorption,
 distribution, metabolism or excretion of drugs and have conditions which include the
 following (but are not limited to): history of major gastrointestinal surgeries
 including gastrectomy, gastro-enterostomy or bowel resection, gastrointestinal bypass
 graft and stabling; current active gastritis, ulcer, gastrointestinal and rectal
 bleeding, presence of active inflammatory bowel syndrome or biliary obstruction with
 the past 12 months.

 11. Subjects with depletion of body fluid or sodium ion not able to correct

 12. Subjects with sever insulin-dependent Diabetes Mellitus(DM) or Chronic DM (HbA1c > 9%
 at Pre-Baseline visit, dosage of an oral hypoglycemic agent was modified within 12
 weeks prior to screening visit , or currently use of active insulin treatment) or with
 hypothyroidism not able to correct.( TSH ≥ 1.5 times upper normal limit)

 13. Subjects with severe heart disease (Heart failure New York Heart Association(NYHA)
 class 3 and 4), or history of any of the followings within the past 6 months; ischemic
 heart disease (e.g. angina pectoris, myocardial infarction), peripheral vascular
 disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass
 graft.

 14. Subjects with clinically significant ventricular tachycardia, atrial fibrillation,
 atrial flutter or any other clinical significant arrhythmia conditions at discretion
 of investigator

 15. Subjects with hypertrophic obstructive cardiomyopathy, severe obstructive coronary
 artery disease, aortic stenosis, hemodynamically significant aortic valve stenosis, or
 mitral valve stenosis.

 16. Subjects with severe cerebrovascular disorder (e.g. stroke, cerebral infarction or
 cerebral hemorrhage within the past 6 months)

 17. Subjects with chronic inflammatory disease requiring an chronic anti-inflammatory
 therapy, past or current medical history with wasting disease, autoimmune diseases
 (e.g. rheumatoid arthritis, systemic lupus erythematosus) or connective tissue
 disease.

 18. Subjects with known moderate or malignant retinosis (e.g. retinal hemorrhage, visual
 disturbance or retinal microaneurysm in the past 6 months)

 19. Subjects with hepatitis B (including positive test for HBsAg), hepatitis C-positive

 20. Subjects with history or evidence of abusing drugs or alcohol within the past 2 years.

 21. Medical history with hypersensitivity to angiotensin II antagonist based drugs or
 HMG-CoA reductase inhibitor based drugs or any ingredient contained in these 2 drugs.

 22. Medical history with clinically significant hypersensitivity to any components or
 other drugs on the investigational product or additives (yellow 5)

 23. Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency
 or glucose-galactose malabsorption.

 24. Pregnant women and lactating female.

 25. Subjects planning pregnancy or childbearing potential who are not using effective
 contraceptive methods (surgical sterilized, intrauterine (contraceptive) device/condom
 or the combination of diaphragm and spermicidal agents)

 26. Subjects who are participating in another trial or took other investigational product
 within 12 weeks prior to Screening visit

 27. Medical history of all kinds of malignant tumor including leukemia and lymphoma in the
 past 5 years

 28. A subject with other reasons not specified above that, ineligible to participate in
 this clinical trial at discretion of study investigators.