A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension
|Essential Hypertension||Drug: Fimasartan 60 mg group Drug: Fimasartan 120 mg group Drug: Reference (Valsartan 80 mg) group||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Diastolic Blood Pressure [ Time Frame: 24 hours ]
|Study Start Date:||December 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Experimental: Fimasartan 1
Fimasartan 60 mg group
Drug: Fimasartan 60 mg group
Fimasartan 60 mg
Other Name: BR-A-657.K
Experimental: Fimasartan 2
Fimasartan 120 mg group
Drug: Fimasartan 120 mg group
Fimasartan 120 mg
Other Name: BR-A-657.K
Active Comparator: Valsartan
Reference (Valsartan 80 mg) group
Drug: Reference (Valsartan 80 mg) group
Reference (Valsartan 80 mg)
Other Name: Diovan
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922441
|Study Chair:||Byung-He Oh, Professor||Seoul National University Hospital|
|Principal Investigator:||Dong-Soo Kim, Professor||Inje University|
|Principal Investigator:||Sung Chul Chae, Professor||Kyungpook National University|
|Principal Investigator:||Gi-Sik Kim, professor||Daegu Catholic University Medical Center|
|Principal Investigator:||Myung-Ho Jung, Professor||Connam National University Hospital|