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Fimasartan/HCTZ combination

Phase 3

Essential Hypertension | Small molecule | Cardiovascular |National Healthcare Corp.|Last Updated: Jan 5, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment263

FDA Designations

No designations recorded

Clinical trial landscape

Fimasartan/HCTZ combination · 1 trial · 1 indication

Phase 3 1
NCT01258673A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapyEssential Hypertension
COMPLETED263 Analytics
PHASE3COMPLETED
A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy
Essential HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Diastolic Blood Pressure
4week

Secondary Endpoints

Systolic Blood Pressure / Diastolic Blood Pressure
4week, 8week / 8week
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fimasartan/HCTZ combination groupEXPERIMENTAL -
Fimasartan groupACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Fimasartan/HCTZ combinationDRUGFimasartan/HCTZ combination 60/12.5mg 120/12.5mg
FimasartanDRUGFimasartan 60mg, 120mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female outpatients 18 years of age and older * Patients with antihypertensive agents at screening: DBP\<110mmHg or Patients without antihypertensive agents at screening: DBP 90mmHg\~120mmHg * Subjects who agree to participate in this sudy and give written informed con...

Countries:South Korea
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Frequently asked questions about Fimasartan/HCTZ combination

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.