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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
 Drug: Fimasartan/HCTZ combination
Drug: Fimasartan
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Diastolic Blood Pressure [ Time Frame: 4week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systolic Blood Pressure / Diastolic Blood Pressure [ Time Frame: 4week, 8week / 8week ] [ Designated as safety issue: No ]

Enrollment: 263
Study Start Date: November 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fimasartan/HCTZ combination group Drug: Fimasartan/HCTZ combination
Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg
Active Comparator: Fimasartan group Drug: Fimasartan
Fimasartan 60mg, 120mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258673

Locations
Korea, Republic of
Seoul National University Hospital, Bundang
Sungnam, Korea, Republic of
Sponsors and Collaborators
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
  More Information

No publications provided by Boryung Pharmaceutical Co., Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01258673     History of Changes
Other Study ID Numbers: BR-FHC-CT-301
Study First Received: December 10, 2010
Last Updated: January 2, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan
Fimasartan/Hydrochlorothiazide combination

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013