NCT00922480

Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients

A Randomized, Double-blind, Losartan-controlled, Parallel Group Comparison Dose Titration Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan 60mg~120mg in Patients With Mild to Moderate Essential Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 506 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) 60 mg\~120 mg in patients with mild to moderate essential hypertension.

Detailed description

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, Losartan-controlled, Parallel Group Comparison Dose Titration Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657•K) 60mg\~120mg in Patients with Mild to Moderate Essential Hypertension. Approximately 480 patients will be enrolled over 12 months in 24 centers nationwide. After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 2 groups. Subjects will take test/control drug for 12 weeks of treatment period. And Extensin study have 12 weeks in treatment period. If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period. If the hypertension is not controlled well, there is a possibility of dose titration. Group I : Fimasartan group. Group II : Losartan group

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Fimasartan	Fimasartan 60 \~ 120mg/po take one tablets once a day
DRUG	Losartan (Control)	Losartan 50 mg \~ 100 mg/po, take one tablets once a day

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2009-06-17
• Last updated: 2018-04-10
• Results posted: 2018-02-13