A Phase 4 interventional study of Placebo and Fimasartan in Essential,Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 8 sites in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-05.
Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 4, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 369 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinically significant renal and liver disorders such as dialysis, cirrhosis, biliary obstruction, cholestasis and liver failure. Patients who have below abnormality in the laboratory results at screening visit.
Subjects have history of any of the followings within the past 6 months or determined clinically significant by investigators.
Placebo daily for 2 weeks and Fimasartan 60mg daily for 2 weeks and 120mg daily for 4 weeks
Drug: Placebo · Drug: Fimasartan
Placebo daily for 2 weeks and Valsartan 80mg daily for 2 weeks and 160mg daily for 4 weeks
Drug: Placebo · Drug: Valsartan
Reference group. Placebo daily for 2 weeks and Olmesartan 10mg daily for 2 weeks and 20mg daily for 4 weeks
Drug: Placebo · Drug: Olmesartan medoxomil
2 weeks of placebo PO daily
60mg 1 tab PO daily for 2 weeks and 120mg 1 tab PO daily for 4 weeks
Also known as: Kanarb Tab
80mg 1 tab PO daily for 2 weeks and 160mg 1 tab PO daily for 4 weeks
Also known as: Diovan Tab
10mg 1 tab PO daily for 2 weeks and 20mg 1 tab PO daily for 4 weeks
Also known as: Olmetec Tab
Change of sitting SBP from baseline after taking investigational products for 6 weeks.
Time frame: 6 weeks from baseline visit
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Boryung Pharmaceutical Co., Ltd