Clinical trial NCT02222480 (phase 2, status: completed)
Conditions: hypertension
ICD codes: I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10
Drugs: fimasartan, hydrochlorothiazide, placebo
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, COCCC1=CC=C(OCC(O)CNC(C)C)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects of no childbearing potential 19-70 years of age

          2. Mean clinic-measured sitting DBP (siDBP) of 90-109 mmHg and mean clinic-measured
             sitting SBP (siSBP) of 140-179 mmHg after a ≥1-week washout of prior antihypertensive
             medications (no wash-out is needed for those not on any antihypertensive medications)
             with a difference of ≤10 mmHg in sitting DBP between before and after run-in

          3. Subjects who agree to participate in this study and give written informed consent

          4. Subjects considered to understand the study, be cooperative, and able to be
             followed-up until the end of the study

        Exclusion Criteria:

          1. Severe hypertension, i.e., mean siDBP ≥110 mmHg or mean siSBP ≥180 mmHg

          2. Orthostatic hypotension with clinically significant signs or symptoms

          3. Secondary hypertension

          4. Not able to stop administration other antihypertensive medications than the study
             drugs (i.e., fimasartan and hydrochlorothiazide) throughout the entire study period

          5. Clinically significant abnormal laboratory test results, e.g., serum creatinine >1.5
             times upper limit of normal, AST, ALT > 2 times upper limit of normal

          6. Conditions that may affect to absorption, distribution, metabolism, and excretion for
             the study drugs

          7. Severe insulin-dependent or uncontrolled diabetes mellitus (HbA1c >9%, increased dose
             of an oral hypoglycemic agent within 12 weeks before screening, or active insulin
             treatment at screening)

          8. Severe cardiovascular diseases within 6 months of screening including ischemic heart
             disease, peripheral vascular disease, significant ventricular tachycardia, atrial
             fibrillation, atrial flutter or other significant arrhythmia, hypertrophic obstructive
             cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis,
             hemodynamically significant aortic valve or mitral valve disease, severe
             cerebrovascular disease

          9. History of percutaneous transluminal coronary angiography or coronary artery bypass
             graft

         10. Chronic debilitating disease, autoimmune disease, connective tissue disease

         11. Positive on serum hepatitis B surface antigen, anti-hepatitis C virus antibody, or
             anti-HIV antibody

         12. History or evidence of alcohol or drug abuse within 2 years

         13. Known allergic reaction to any angiotensin receptor blockers

         14. Chronic inflammation disease requiring chronic anti-inflammation therapy

         15. Women of childbearing potential without any contraceptive measure or breast-feeding
             mother

         16. Prior participation in a clinical trial of any investigational products within 12
             weeks from screening

         17. Serum potassium <3.5 mmol/L or >5.5 mmol/L at any time of the study period

         18. Depletion of sodium ion or body fluid, which cannot be corrected easily during the
             study period

         19. Evidence of hereditary disease, including galactose intolerance, Lapp lactase
             deficiency, or glucose-galactose malabsorption.

         20. Considered unsuitable to participate in the study under the discretion of the
             principal investigator