A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild to Moderate Essential Hypertension
After subjects have signed informed consent voluntarily, when they are taking hypertension medication, they go through screening period for 7 days including wash-out period. After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days), and evaluate their suitability to Inclusion and Exclusion criteria. Patients, who evaluated the proper subject for this clinical trial, are allocated to experimental group (Fimasartan 30mg) or Control group (Placebo group) or Reference group (Valsartan 80mg) randomly at a ratio 2:2:1 and their investigational drugs will be administered daily for the study period (8 weeks). Subjects visit their investigators twice during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks. The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
293
Severance Hospital
Seoul, South Korea
the difference of sitting DBP
To compare the difference of sitting DBP between fimasartan 30mg group and placebo group
Time frame: After 8 weeks from baseline visit
the difference of sitting DBP
To compare the difference of sitting DBP between fimasartan 30mg group and valsartan 80mg group
Time frame: After 8 weeks from baseline visit
the difference of SiDBP
To compare the difference of SiDBP among fimasartan 30mg group, valsartan 80mg and placebo group
Time frame: After 4 weeks from baseline visit
the difference of SiSBP
To compare the difference of SiSBP among fimasartan 30mg group, valsartan 80mg and placebo group
Time frame: After 4 weeks and 8 weeks from baseline visit
the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg)
To compare the ratio of responder(SiDBP\<90mmHg or ΔSiDBP≥10mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group
Time frame: After 8 weeks from baseline visit
the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg & SiSBP<140mmHg)
To compare the ratio of subjects who get normalized blood pressure(SiDBP\<90mmHg \& SiSBP\<140mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group
Time frame: After 8 weeks from baseline visit
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