A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide

Study Overview
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Brief Summary
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A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension

Official Title
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A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination With Hydrochlorothiazide in Patients With Mild to Moderate Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Fimasartan
* Drug: Hydrochlorothiazide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects of no childbearing potential 19-70 years of age 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 Subjects who agree to participate in this study and give written informed consent Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study Exclusion Criteria: Severe hypertension, i.e., mean siDBP ≥110 mmHg or mean siSBP ≥180 mmHg Orthostatic hypotension with clinically significant signs or symptoms Secondary hypertension Not able to stop administration other antihypertensive medications than the study drugs (i.e., fimasartan and hydrochlorothiazide) throughout the entire study period 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 Conditions that may affect to absorption, distribution, metabolism, and excretion for the study drugs 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) 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 History of percutaneous transluminal coronary angiography or coronary artery bypass graft Chronic debilitating disease, autoimmune disease, connective tissue disease Positive on serum hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-HIV antibody History or evidence of alcohol or drug abuse within 2 years Known allergic reaction to any angiotensin receptor blockers Chronic inflammation disease requiring chronic anti-inflammation therapy Women of childbearing potential without any contraceptive measure or breast-feeding mother Prior participation in a clinical trial of any investigational products within 12 weeks from screening Serum potassium <3.5 mmol/L or >5.5 mmol/L at any time of the study period Depletion of sodium ion or body fluid, which cannot be corrected easily during the study period Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Considered unsuitable to participate in the study under the discretion of the principal investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fimasartan 60 mg, Hydrochlorothiazide 12.5 mg<br>Combination of Fimasartan/Hydrochlorothiazide 60/12.5mg | Drug: Fimasartan<br> <br> Drug: Hydrochlorothiazide<br> <br> |
| Experimental: Fimasartan 60 mg, Hydrochlorothiazide 25 mg<br>Combination of Fimasartan/Hydrochlorothiazide 60/25mg | Drug: Fimasartan<br> <br> Drug: Hydrochlorothiazide<br> <br> |
| Experimental: Fimasartan 120 mg, Hydrochlorothiazide 12.5 mg<br>Combination of Fimasartan/Hydrochlorothiazide 120/12.5mg | Drug: Fimasartan<br> <br> Drug: Hydrochlorothiazide<br> <br> |
| Experimental: Fimasartan 120 mg, Hydrochlorothiazide 25 mg<br>Combination of Fimasartan/Hydrochlorothiazide 120/25mg | Drug: Fimasartan<br> <br> Drug: Hydrochlorothiazide<br> <br> |
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of treatment in 24-hour mean systolic blood pressure (SBP) using ambulatory blood pressure monitoring (ABPM) |  | from baseline to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients, with mild, moderate, essential