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

A Randomized, Double-blind, Multicenter Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Controlled by Fimasartan 60mg(Phase 3)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01258673

Enrollment

263

Registered

2010-12-13

Start date

2010-11-30

Completion date

Unknown

Last updated

2012-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

Fimasartan, Fimasartan/Hydrochlorothiazide combination

Brief summary

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.

Interventions

DRUGFimasartan/HCTZ combination

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

DRUGFimasartan

Fimasartan 60mg, 120mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Diastolic Blood Pressure	4week

Secondary

Measure	Time frame
Systolic Blood Pressure / Diastolic Blood Pressure	4week, 8week / 8week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026