The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.
A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit. During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
290
Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
KyungPook National University Hospital
Daegu, Daegu, South Korea
Sitting Diastolic Blood Pressure
To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 60mg with Candesartna 8mg
Time frame: 12weeks from baseline visit
Sitting DBP
To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 120mg with Candesartna 8mg
Time frame: at 12weeks from Baseline visit
SittingDBP
To compare the difference of Sitting Diastolic Blood Pressure at 4, 8 weeks from baseline visit Fimasartan 60/120mg with Candesartna 8mg
Time frame: at 4, 8 weeks from baseline visit
Sitting Systolic Blood Pressure
To compare the difference of Sitting Systolic Blood Pressure at 4,8,12 weeks from baseline visit Fimasartan 60mg/120mg with Candesartna 8mg
Time frame: at 4,8,12 weeks from baseline visit
Responder ratio
To compare the ratio or responder(SiDBP\<90mmHg or difference of SiDBP\>10mmHg from baseline) at 12 weeks Fimasartan 60mg/120mg with Candesartna 8mg
Time frame: at 12weeks from baseline visit
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