Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00922480|
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Fimasartan Drug: Losartan (Control)||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||506 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2008|
|Primary Completion Date :||July 2009|
|Study Completion Date :||September 2009|
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
- Diastolic Blood Pressure Change [ Time Frame: 12 week ]DBP(Week 12) - DBP(Baseline) while in a sitting position
- Diastolic Blood Pressure Change [ Time Frame: 4 week, 8 week ]DBP(Week 4, 8) - DBP(Baseline) while in a sitting position
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): NCT00922480
|Principal Investigator:||Byung-Hee Oh, MD||Seoul National University Hospital|