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Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients

This study has been completed.
Sponsor:
Collaborators:
Seoul National University Hospital
Samsung Medical Center
Asan Medical Center
Seoul National University Bundang Hospital
The Catholic University of Korea
Severance Hospital
Yonsei University
Cheil General Hospital and Women’s Healthcare Center
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00923611
First received: June 16, 2009
Last updated: June 17, 2009
Last verified: June 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8 week treatment with Fimasartan (BR-A-657-K) 20, 60, 120, 240 mg and placebo in patients with mild to moderate essential hypertension and to determine the adequate antihypertensive dosage for later clinical study.


Condition Intervention Phase
Hypertension
 Drug: Fimasartan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Grouped, Clinical Study to Evaluate the Antihypertensive Efficacy and Tolerability and to Determine the Adequate Antihypertensive Dosage of Fimasartan(BR-A-657-K) in Patients With Mild to Moderate Essential Hypertension

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • change from baseline to end of 8 week treatment in sitting diastolic blood pressure [ Time Frame: 8 week from baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change from baseline to end of 2,4 week treatment in sitting diastolic blood pressure [ Time Frame: 2, 4 week from baseline ] [ Designated as safety issue: Yes ]
  • change from baseline to end of 2,4,8 week treatment in sitting systolic blood pressure [ Time Frame: 2,4,8 week from baseline ] [ Designated as safety issue: Yes ]
  • responders after end of 8 week treatment(portion of DBP<90mmHg or the difference from baseline and end of 8 week treatment>10mmHg [ Time Frame: 8 week from baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 182
Study Start Date: September 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
3 tablets of placebo will be taken 30minutes after breakfast for 8 weeks
 Drug: Fimasartan
Active Comparator: Fimasartan 20mg
2 tablets of placebo and 1 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
 Drug: Fimasartan
Active Comparator: Fimasartan 60mg
3 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
 Drug: Fimasartan
Active Comparator: Fimasartan 120mg
3 tablets of fimasartan 40mg will be taken 30minutes after breakfast
 Drug: Fimasartan
Active Comparator: Fimasartan 240mg
3 tablets of fimasartan 80mg will be taken 30minutes after breakfast for 8 weeks
 Drug: Fimasartan

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, placebo-controlled, parallel grouped, clinical study will be conducted to evaluate the antihypertensive efficacy and tolerability and to determine adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate essential hypertension.

Approximately 182 patients will be enrolled over 12 months in 8 centers nationwide.

After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 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 : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV : Fimasartan 120 mg, Group V : Fimasartan 240 mg,

  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 Screening and Baseline(Day1) are 95~114 mmHg inclusive and the difference between sitting diastolic blood pressures measured at Day -14 and Baseline(Day1) 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 94mmHg or more than 115mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg
  • Patients with secondary hypertension
  • 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 3 months, 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 with average weight > +35% or <-15% in Modified Metropolitan Life Insurance table
  • Patients participated other clinical trial 3 months 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: NCT00923611

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Seoul National University Hospital
Samsung Medical Center
Asan Medical Center
Seoul National University Bundang Hospital
The Catholic University of Korea
Severance Hospital
Yonsei University
Cheil General Hospital and Women’s Healthcare Center
Investigators
Study Chair: Byung-Hee Oh, Professor Seoul National University Hospital
Principal Investigator: Jae-Joong Kim, Professor Asan Medical Center
Principal Investigator: Eun-Suk Jeon, Professor Samsung Medical Center
Principal Investigator: Dong-Ju Choi, Professor Seoul National University Bundang Hospital
Principal Investigator: Ki-Bae Seong, Professor Kangnam ST.Mary's Hospital
Principal Investigator: Jong-Won Ha, Professor Severance Hospital
Principal Investigator: Se-Joong Lim, Professor Yonsei University
Principal Investigator: Jeong-Bae Park, Professor Cheil General Hospital and Women’s Healthcare Center
  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: Choi, Director, Boryung Pharm Co., Inc.
ClinicalTrials.gov Identifier: NCT00923611     History of Changes
Other Study ID Numbers: A-657-BR-CT-202
Study First Received: June 16, 2009
Last Updated: June 17, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Hypertension
Fimasartan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013