Clinical trial NCT02152306 (phase 3, status: completed)
Conditions: essential hypertension
ICD codes: I10, O10.02, O10.03, O10.011, O10.012, O10.013, O10.019
Drugs: fimasartan and amlodipine, fimasartan
SMILES: CCCCC1=NC(C)=C(CC(=S)N(C)C)C(=O)N1CC1=CC=C(C=C1)C1=C(C=CC=C1)C1=NN=NN1, CCCCC1=NC(C)=C(CC(=S)N(C)C)C(=O)N1CC1=CC=C(C=C1)C1=C(C=CC=C1)C1=NN=NN1
Eligibility criteria:

        Inclusion Criteria:

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

          2. Male and Female between 20 and 75 years old

          3. Patients with essential hypertension

          4. Patients who is unresponsive to Fimasartan 60mg monotherapy for 4 weeks (i.e. the mean
             SiDBP from 3 times of measurement is 140mmHg ≤ SiSBP <180 mmHg)

          5. Understand the trial procedures and be willing to cooperate and complete the trial.

        Exclusion Criteria:

          1. Severe Hypertension patients (SiDBP ≥ 110mmHg and/or SiSBP ≥ 180mmHg)

          2. Subjects with the difference between blood pressures from a selected arm, SiDBP ≥10
             mmHg or SiSBP ≥20 mmHg, at screening assessment

          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, pheochromo-cytoma, polycystic kidney disease, etc.)

          4. Clinically significant renal function abnormality in the laboratory results at
             screening (i.e. serum creatine ≥ 1.5 times upper normal limit (UNL)), liver function
             abnormality (ALT, AST ≥ 2 times upper normal limit (UNL)), severe fatty liver disease
             that requires medication

          5. Clinically significant Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded
             5.5mmol/L)

          6. 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 stapling; current active gastritis, ulcer, gastrointestinal and rectal
             bleeding, presence of active inflammatory bowel syndrome within the past 12 months; or
             clinically significant urinary obstruction at discretion of investigator

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

          8. Subjects with severe insulin-dependent Diabetes Mellitus (DM) or chronic DM (HbA1c>9%,
             dosage of an oral hypoglycemic agent was modified within the past 12 weeks, or use of
             active insulin treatment at screening)

          9. Subjects with severe heart disease (heart failure New York Heart Association(NYHA)
             Class III and IV), 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.

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

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

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

         13. 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.

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

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

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

         17. Medical history with hypersensitivity to angiotensin II antagonist-based drugs or
             calcium-channel blockers

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

         19. Pregnant women and lactating female

         20. Women of childbearing potential who are not using effective contraceptive methods.
             (Excluding subjects who had surgically sterilized. All women of childbearing potential
             who did not have surgical sterilization must prove negative in a pregnancy test, and
             continue to use accepted and effective contraceptive methods until the end of the
             study in order to participate. Not accepted contraceptive method: Periodic abstinence
             and celibacy (e.g. Basic body temperature method, menstrual cycle calculation),
             hormonal contraceptives.

         21. Subject who is participating in another trial or took other investigational product
             within12 weeks from the screening visit

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

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