Clinical trial NCT01258673: A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Fimasartan
Fimasartan/Hydrochlorothiazide combination
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Hospital
name: The Catholic University of Korea
name: Korea University Guro Hospital
name: DongGuk University
name: Seoul National University Bundang Hospital
name: Samsung Medical Center
name: Asan Medical Center
name: Gangnam Severance Hospital
name: Severance Hospital
name: Ajou University
name: Chonbuk National University Hospital
name: Cheil General Hospital and Women's Healthcare Center
name: Chonnam National University Hospital
name: Hanyang University
name: Yonsei University
name: Ilsan-Paik Hospital
name: SMG-SNU Boramae Medical Center
name: Kyung Hee University Hospital
First posted: 2010-12-13
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diastolic Blood Pressure
timeFrame: 4week
Secondary outcomes:
measure: Systolic Blood Pressure / Diastolic Blood Pressure
timeFrame: 4week, 8week / 8week
Other outcomes:
Locations:
city: Sungnam
country: Korea, Republic of
facility: Seoul National University Hospital, Bundang
Study officials:
References:
citation: Rhee MY, Baek SH, Kim W, Park CG, Park SW, Oh BH, Kim SH, Kim JJ, Shin JH, Yoo BS, Rim SJ, Ha JW, Doh JH, Ahn Y, Chae JK, Park JB, Kim SK, Kim CH. Efficacy of fimasartan/hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy. Drug Des Devel Ther. 2015 Jun 2;9:2847-54. doi: 10.2147/DDDT.S82098. eCollection 2015.
citation: Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.