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Fimasartan

Phase 3

Hypertension | Small molecule | Cardiovascular |National Healthcare Corp.|Last Updated: Apr 10, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment688

FDA Designations

No designations recorded

Clinical trial landscape

Fimasartan · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00922480Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension PatientsHypertension
COMPLETED506 Analytics
PHASE3COMPLETED
Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients
Hypertension
NCT00922480506
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Study Endpoints

Primary Endpoints

Diastolic Blood Pressure Change
baseline and 12 weeks

Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position

change from baseline to end of 8 week treatment in sitting diastolic blood pressure
8 week from baseline

Secondary Endpoints

Diastolic Blood Pressure Change
baseline and 4 weeks, 8 weeks
change from baseline to end of 2,4 week treatment in sitting diastolic blood pressure
2, 4 week from baseline
change from baseline to end of 2,4,8 week treatment in sitting systolic blood pressure
2,4,8 week from baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
2ACTIVE_COMPARATORLosartan group
1ACTIVE_COMPARATORFimasartan 60mg, 120mg
PlaceboPLACEBO_COMPARATOR3 tablets of placebo will be taken 30minutes after breakfast for 8 weeks
Fimasartan 20mgACTIVE_COMPARATOR2 tablets of placebo and 1 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
Fimasartan 60mgACTIVE_COMPARATOR3 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
Fimasartan 120mgACTIVE_COMPARATOR3 tablets of fimasartan 40mg will be taken 30minutes after breakfast
Fimasartan 240mgACTIVE_COMPARATOR3 tablets of fimasartan 80mg will be taken 30minutes after breakfast for 8 weeks

Interventions

NameTypeDescription
FimasartanDRUGFimasartan 60 \~ 120mg/po take one tablets once a day
Losartan (Control)DRUGLosartan 50 mg \~ 100 mg/po, take one tablets once a day
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Placebo visit and Baseline are 90\~109mmHg inclusive and the difference between sitting diastolic blood pressures measured at Placebo visit and Baseline(Day0) is under 7mmHg. * Subjects who ...

Countries:South Korea
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Competitive Landscape -Hypertension 40 trials

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS2PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
AstraZeneca PLCAZN2 - Undisclosed
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
Orchestra BioMed Holdings, Inc.OBIO3N/AUndisclosed
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
CVRx, Inc.CVRX1N/AMedical Management
Medtronic PlcMDT4N/AUndisclosed
IQVIA Holdings IncIQV1N/AUndisclosed
Verve Medical, IncVERV1N/AActive hypertension medical therapy
Tango Therapeutics, Inc.TNGX1N/ATriple Fixed-Dose Combination, Usual Care Antihypertensive Regimen
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Frequently asked questions about Fimasartan

What is Fimasartan used for?

Fimasartan is an investigational small molecule being developed for the treatment of hypertension, including essential hypertension. It is a cardiovascular therapeutic currently in Phase 3 clinical development. Fimasartan has been studied in clinical trials for its antihypertensive efficacy and safety in patients with hypertension.

Who is developing Fimasartan?

Fimasartan is being developed by National Healthcare Corp., a company listed under the ticker NHC. The drug is currently in Phase 3 clinical development for the treatment of hypertension and essential hypertension.

What phase is Fimasartan in?

Fimasartan is in Phase 3 clinical development. It has completed two Phase 3 trials and one Phase 2 trial, all of which were randomized, double-blind, and placebo-controlled. Fimasartan is not yet approved and remains investigational.

What clinical trials is Fimasartan in?

Fimasartan has completed several clinical trials, including NCT00922480, a Phase 3 study in hypertension patients with 506 participants, and NCT01258673, a Phase 3 study of Fimasartan in combination with hydrochlorothiazide for essential hypertension with 263 participants. A Phase 2 trial, NCT00923611, enrolled 182 patients with mild to moderate essential hypertension.

Is Fimasartan the same as Fimasartan/Hydrochlorothiazide?

Fimasartan is the single-agent drug, while Fimasartan/Hydrochlorothiazide is a combination therapy that includes Fimasartan plus hydrochlorothiazide. The combination has been studied in a Phase 3 clinical trial for essential hypertension, but it is a separate formulation from Fimasartan alone.

How does Fimasartan work?

Fimasartan is a small molecule antihypertensive agent. Its specific molecular target has not been disclosed in the available clinical trial information. It is being studied for its ability to lower blood pressure in patients with hypertension and essential hypertension.