Essential Hypertension Clinical Trial
Official title:
Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Antihypertensive Efficacy, Safety, Tolerability, and Pharmacodynamic/Pharmacokinetic Profiles After 4 Weeks of Oral Administration of Fimasartan(BR-A-657) at 20-180mg in Patients With Essential Hypertension
Study objective:
1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after
the oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with
essential hypertension.
2. To review the pharmacokinetic profile after the multiple administration and the
pharmacodynamic profile regarding the renin-angiotensin system, after the oral
administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential
hypertension.
3. To determine the dose for the clinical study at the next phase by analyzing the
relationship between the antihypertensive efficacy and pharmacokinetic •
pharmacodynamic results.
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, placebo-controlled, parallel grouped, clinical study will be
conducted to evaluate the antihypertensive efficacy and tolerability and to determine
adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate
essential hypertension.
Approximately 60 patients will be enrolled over 12 months in Seoul National University
Hospital.
After 2 weeks of placebo run-in period, all subjects will be randomized into one of the
following 5 groups. Subjects will take test drug/placebo for 28 days of treatment period. If
subjects take any antihypertensive medications before screening, the subjects will have 1
week of wash-out period.
Group I : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV :
Fimasartan 180 mg
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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