A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Brief Summary

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The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan/Hydrochlorothiazide combination 60/12.5mg\~120/12.5mg in patients with essential hypertension who are not controlled by fimasartan 60mg.

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fimasartan/HCTZ combination group

Group Type EXPERIMENTAL

Fimasartan/HCTZ combination

Intervention Type DRUG

Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg

Fimasartan group

Group Type ACTIVE_COMPARATOR

Fimasartan

Intervention Type DRUG

Fimasartan 60mg, 120mg

Interventions

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Fimasartan/HCTZ combination

Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg

Intervention Type DRUG

Fimasartan

Fimasartan 60mg, 120mg

Intervention Type DRUG

Eligibility Criteria

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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 consent
* Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
* Patients with not controlled blood pressure at baseline visit, by fimasartan 60mg 4weeks treatment, DBP 90mmHg\~109mmHg and SBP\<180mmHg

Exclusion Criteria

* The sitting DBP is more than 120mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension
* Patients who are measured the mean difference of mean blood pressure under SiDBP 10mmHg or SiSBP 20mmHg at screening or baseline visit
* Patients with severe renal(Creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
* Patients with postural hypotension
* Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c\>9%, regimen change of oral hypoglycemic agents within 12weeks, treated insulin before screening)
* Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
* Patients with consumptive disease, autoimmune disease, connective tissue disease
* Patients with a history of type B or C hepatitis(include carrier)
* Patients with HIV or hepatitis
* Patients with clinically significant laboratory abnormality
* Patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure
* Patients with allergy or contraindication to any angiotensin II receptor antagonists
* Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
* Patients judged to have a history of alcohol or drug abuse by the investigator
* Patients participated other clinical trial 12 weeks before Screening - Patients judged to be inappropriate for this study by the investigator with other reasons

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No