Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boryung Pharmaceutical Co., Ltd
With
Seoul National University Hospital
Age
19–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
Clareo Health | A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide
