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The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.
A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit.
During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Fimasartan 60mg, Fimasartan 120mg, Candesartan cilexetil
KyungPook National University Hospital
Korea, Republic of
Boryung Pharmaceutical Co., Ltd
Published on BioPortfolio: 2014-08-27T03:13:15-0400
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To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen
A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and A...
To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.
Fimasartan is the ninth and latest Angiotensin Receptor Blockers for the treatment of hypertension. Fimasartan is a derivative of losartan in which the imidazole ring has been replaced, a change that ...
The comparison of antihypertensive effects between telmisartan and candesartan in patients with essential hypertension has been investigated in several small studies. The results were not consistent. ...
Fimasartan (FMS), an angiotensin II receptor antagonist, is metabolized to FMS S-oxide, FMS N-glucuronide, oxidative desulfurized FMS (BR-A-557), and hydroxy-n-butyl FMSs. The purpose of this study wa...
Candesartan is one of the standard antihypertensive drug belonging to AT1R angiotensin receptor blockers (ARBs) group. Beneficial effects of this drug in the treatment of hypertension are well recogni...
During the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial, patients with hypertension who received amlodipine had similar cardiovascular risks as those who received candesart...
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