Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Diastolic Blood Pressure [ Time Frame: 12 week ] [ Designated as safety issue: No ]
- Diastolic Blood Pressure [ Time Frame: 4 week, 8 week ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 2
Drug: Losartan (Control)
Losartan 50 mg ~ 100 mg/po, take one tablets once a day
Other Name: Cozar
Active Comparator: 1
Fimasartan 60mg, 120mg
Fimasartan 60 ~ 120mg/po take one tablets once a day
Other Name: A657-BR-CT
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922480
|Principal Investigator:||Byung-Hee Oh, MD||Seoul National University Hospital|