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
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|ClinicalTrials.gov Identifier: NCT00922441|
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : February 13, 2018
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension||Drug: Fimasartan 60 mg group Drug: Fimasartan 120 mg group Drug: Reference (Valsartan 80 mg) group||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
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
- Mean Change of Diastolic Blood Pressure [ Time Frame: baseline and 8 Weeks ]24hr Mean change of DBP on Week 8, from Baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hospital|
|Principal Investigator:||Gi-Sik Kim, professor||Daegu Catholic University Medical Center|
|Principal Investigator:||Myung-Ho Jung, Professor||Connam National University Hospital|