Status:
COMPLETED
A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsors:
Seoul National University Hospital
Conditions:
Hypertension
Eligibility:
All Genders
19-70 years
Phase:
PHASE2
Brief Summary
A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination with Hydroc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT02222480
Start Date
October 1 2014
End Date
June 1 2015
Last Update
July 1 2016
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744