The purpose of this study is to evaluate the efficacy and safety of Fimasartan compared to Valsartan and Olmesartan(reference group) in patients with mild to moderate essential hypertension. Patients have 2 weeks of placebo run-in and wash out period, 2 weeks of taking required dose and 4 weeks of taking double dose.
A randomized, double-blind, active control, 3-parallel group comparison clinical study to evaluate the anti-hypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension. Approximately 360 patients will be enrolled in 8 centers in South Korea. This study has planned 6 visits during 8 weeks.(2 weeks of placebo run-in and wash out, 2 weeks of treatment and 4 weeks of forced titration) All of the subjects who agreed to participate in this study and gave written informed consent voluntarily are assessed the inclusion and exclusion criteria and receive the investigational product(placebo) at screening visit. During more than 14 days of placebo run-in and wash out period, subjects have to stop the previous anti-hypertensive drug. After placebo run-in and wash out period, Subjects are assessed the final eligibility and started measuring ambulatory blood pressure for 24 hours. Subjects who determined to be appropriate for this study are allocated to experimental group(Fimasartan 60mg) or control group(Valsartan 80mg) or Reference group(Olmesartan 10mg) randomly at ratio 3:3:1.Subjects take their investigational products daily for 2 weeks and double dose for 4 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
QUADRUPLE
Enrollment
369
2 weeks of placebo PO daily
60mg 1 tab PO daily for 2 weeks and 120mg 1 tab PO daily for 4 weeks
80mg 1 tab PO daily for 2 weeks and 160mg 1 tab PO daily for 4 weeks
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Banpo-dong, Seocho-gu, South Korea
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Bupyeong-gu, South Korea
The Catholic University of Korea, St. Paul's Hospital
Seoul, Dongdaemun-gu, South Korea
Change of sitting SBP from baseline after taking investigational products for 6 weeks.
Time frame: 6 weeks from baseline visit
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10mg 1 tab PO daily for 2 weeks and 20mg 1 tab PO daily for 4 weeks
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St.Vincent's Hospital.
Suwon, Gyeonggi-do, South Korea
The Catholic University of Korea,Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, Jung-gu/Daeheung-ro, South Korea
The Catholic University of Korea,Yeouido St.Mary's Hospital
Seoul, Yeongdeungpo-gu, South Korea