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A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension

This study has been completed.
Sponsor:
Collaborators:
Seoul National University Hospital
Kyungpook National University
Catholic Medical Center
Inje University
Chonnam National University Hospital
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00922441
First received: June 16, 2009
Last updated: December 14, 2010
Last verified: December 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension.


Condition Intervention Phase
Essential Hypertension
 Drug: Fimasartan 60 mg group
Drug: Fimasartan 120 mg group
Drug: Reference (Valsartan 80 mg) group
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Valsartan-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) During 24hours by Dose in Patients With Mild to Moderate Essential Hypertension

Resource links provided by NLM:

Drug Information available for: Valsartan
U.S. FDA Resources

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

Primary Outcome Measures:
  • Diastolic Blood Pressure [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fimasartan 1
Fimasartan 60 mg group
 Drug: Fimasartan 60 mg group
Fimasartan 60 mg
Experimental: Fimasartan 2
Fimasartan 120 mg group
 Drug: Fimasartan 120 mg group
Fimasartan 120 mg
Active Comparator: Valsartan
Reference (Valsartan 80 mg) group
 Drug: Reference (Valsartan 80 mg) group
Reference (Valsartan 80 mg)

Detailed Description:

Fimasartan(BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan(BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan(BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan(BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A Randomized, Double-blind, Valsartan-referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) during 24hoursby dose in Patients with Mild to Moderate Essential Hypertension.

Approximately 90 patients will be enrolled over 12 months in 5 centers nationwide.

After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 3 groups. Subjects will take test/control drug for 8 weeks of treatment period.

If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.

Group I : Fimasartan 60mg group. Group II : Fimasartan 120mg group Group III : Valsartan 80mg group

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Placebo visit and Baseline are 90~109mmHg inclusive and the difference between sitting diastolic blood pressures measured at Placebo visit and Baseline(Day0) is under 7mmHg.
  • 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

Exclusion Criteria:

  • The sitting DBP is less than 89mmHg or more than 110mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension
  • Patients with severe renal(Creatinine more 1.5mg/dl), 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
  • 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: NCT00922441

Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Seoul National University Hospital
Kyungpook National University
Catholic Medical Center
Inje University
Chonnam National University Hospital
Investigators
Study Chair: Byung-He Oh, Professor Seoul National University Hospital
Principal Investigator: Dong-Soo Kim, Professor Inje University
Principal Investigator: Sung Chul Chae, Professor Kyungpook National University
Principal Investigator: Gi-Sik Kim, professor Daegu Catholic University Medical Center
Principal Investigator: Myung-Ho Jung, Professor Connam National University Hospital
  More Information

No publications provided

Responsible Party: Choi, Jeongeun / Director, Boryung Pharm. Co., Ltd
ClinicalTrials.gov Identifier: NCT00922441     History of Changes
Other Study ID Numbers: A657-BR-CT-203
Study First Received: June 16, 2009
Last Updated: December 14, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan
Essential Hypertension
24hour ABPM
Population PK

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Antihypertensive Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013