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

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01258673
First received: December 10, 2010
Last updated: January 2, 2012
Last verified: December 2010

December 10, 2010
January 2, 2012
November 2010
December 2011   (final data collection date for primary outcome measure)
Diastolic Blood Pressure [ Time Frame: 4week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01258673 on ClinicalTrials.gov Archive Site
Systolic Blood Pressure / Diastolic Blood Pressure [ Time Frame: 4week, 8week / 8week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Essential Hypertension
  • Drug: Fimasartan/HCTZ combination
    Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg
  • Drug: Fimasartan
    Fimasartan 60mg, 120mg
  • Experimental: Fimasartan/HCTZ combination group
    Intervention: Drug: Fimasartan/HCTZ combination
  • Active Comparator: Fimasartan group
    Intervention: Drug: Fimasartan
[No authors listed] Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
263
Not Provided
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01258673
BR-FHC-CT-301
Yes
Boryung Pharmaceutical Co., Ltd
Boryung Pharmaceutical Co., Ltd
  • 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
Not Provided
Boryung Pharmaceutical Co., Ltd
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP