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

Tracking Information
First Submitted Date ICMJE	December 10, 2010
First Posted Date ICMJE	December 13, 2010
Last Update Posted Date	January 5, 2012
Study Start Date ICMJE	November 2010
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 10, 2010)	Diastolic Blood Pressure [ Time Frame: 4week ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01258673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 10, 2010)	Systolic Blood Pressure / Diastolic Blood Pressure [ Time Frame: 4week, 8week / 8week ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy
Official Title ICMJE	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)
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Essential Hypertension
Intervention ICMJE	Drug: Fimasartan/HCTZ combination Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg; Drug: Fimasartan Fimasartan 60mg, 120mg
Study Arms	Experimental: Fimasartan/HCTZ combination group Intervention: Drug: Fimasartan/HCTZ combination; Active Comparator: Fimasartan group Intervention: Drug: Fimasartan
Publications *	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.; Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000. Review.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 2, 2012)	263
Original Estimated Enrollment ICMJE; (submitted: December 10, 2010)	250
Study Completion Date	Not Provided
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01258673
Other Study ID Numbers ICMJE	BR-FHC-CT-301
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Boryung Pharmaceutical Co., Ltd
Study Sponsor ICMJE	Boryung Pharmaceutical Co., Ltd
Collaborators ICMJE	Seoul National University Hospital; The Catholic University of Korea; Korea University Guro Hospital; DongGuk University; Seoul National University Bundang Hospital; Samsung Medical Center; Asan Medical Center; Gangnam Severance Hospital; Severance Hospital; Ajou University; Chonbuk National University Hospital; Cheil General Hospital and Women’s Healthcare Center; Chonnam National University Hospital; Hanyang University; Yonsei University; Ilsan-Paik Hospital; SMG-SNU Boramae Medical Center; Kyung Hee University Hospital
Investigators ICMJE	Not Provided
PRS Account	Boryung Pharmaceutical Co., Ltd
Verification Date	December 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP