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

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Fimasartan/HCTZ combination; Drug: Fimasartan

• Registration Number: NCT01258673
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Status Verified: 2010-12
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-13
• Primary Completion: 2011-12
• Last Update Submitted: 2012-01-02
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fimasartan/HCTZ combination group	Fimasartan/HCTZ combination	-
Fimasartan group	Fimasartan	-

Primary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure	4week

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure / Diastolic Blood Pressure	4week, 8week / 8week

Trial Locations

Locations (1)

Seoul National University Hospital, Bundang; 🇰🇷 Sungnam, Korea, Republic of