A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
The objective of this clinical study is to evaluate the efficacy and safety by comparing the
 fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the
 placebo/atorvastatin treatment group respectively at Week 8 in patients with essential
 hypertension and dyslipidemia.
Inclusion Criteria:

 1. Voluntarily provided a written consent to participate in this clinical study

 2. Male or female adults aged 19-70 years

 3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening
 visit (V1)

 4. Uncontrolled blood pressure (140 mmHg ≤ mean SiSBP < 180 mmHg) at the pre- baseline
 visit (V2) after wash-out period

 5. Able to understand this study, be cooperative in the execution of the study, and
 participate in the study until its completion

 Exclusion Criteria:

 1. Severe hypertension with mean Sitting systolic blood pressure(SiSBP)≥180 mmHg or
 Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the
 pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms

 2. Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic
 blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times at the
 screening visit (V1)

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

 4. Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline
 visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit at the
 pre-baseline visit (V2))

 5. Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or
 ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular
 diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous
 transluminal coronary angioplasty, or coronary artery bypass graft, etc.

 6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter;
 or other arrhythmia conditions that are determined to be clinically significant by the
 investigator

 7. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease,
 aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve
 stenosis

 8. Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic
 attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)

 9. Pregnant or lactating women