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

Boryung

Status and phase

Completed

Phase 3

Conditions

Essential Hypertension

Treatments

Drug: Fimasartan

Drug: Fimasartan/HCTZ combination

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01258673

BR-FHC-CT-301

Details and patient eligibility

About

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.

Enrollment

263 patients

Sex

All

Ages

18+ years old

Volunteers

No 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