Essential Hypertension Clinical Trial
Official title:
A Randomized, Double-blind, Valsartan-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) During 24hours by Dose in Patients With Mild to Moderate Essential Hypertension
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension.
Fimasartan(BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and
potent antihypertensive effect in many hypertensive models. Phase I study,
Fimasartan(BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that
the Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study,
Fimasartan(BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that
Fimasartan(BR-A-657-K) was safe and tolerable though one temporal adverse event was observed
in high dose.
A Randomized, Double-blind, Valsartan-referenced, Parallel Grouped, Therapeutic Exploratory
Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) during
24hoursby dose in Patients with Mild to Moderate Essential Hypertension.
Approximately 90 patients will be enrolled over 12 months in 5 centers nationwide.
After 2 weeks of placebo run-in period, all subjects will be randomized into one of the
following 3 groups. Subjects will take test/control drug for 8 weeks of treatment period.
If subjects take any antihypertensive medications before screening, the subjects will have 1
week of wash-out period.
Group I : Fimasartan 60mg group. Group II : Fimasartan 120mg group Group III : Valsartan 80mg
group
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