A Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension (fimasartan)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Boryung Pharmaceutical Co., Ltd.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Catholic University of Korea
Konyang University Hospital
Korea University
Ilsan Hospital
Daegu Fatima Hospital
Dong-A University
Soon Chun Hyang University
Asan Medical Center
Gangnam Severance Hospital
Severance Hospital
Ulsan University Hospital
Eulji University Hospital
Kangbuk Samsung Hospital
Sejong General Hospital
Ewha Womans University Mokdong Hospital
Jeju National University Hospital
Hallym University Medical Center
Hanyang University
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01672476
First received: August 20, 2012
Last updated: September 4, 2012
Last verified: August 2012
  Purpose

A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild to Moderate Essential Hypertension


Condition Intervention Phase
Hypertension
Drug: Placebo
Drug: Valsartan
Drug: Fimasartan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension

Resource links provided by NLM:


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

Primary Outcome Measures:
  • the difference of sitting DBP [ Time Frame: After 8 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    To compare the difference of sitting DBP between fimasaratn 30mg group and placebo group


Secondary Outcome Measures:
  • the difference of sitting DBP [ Time Frame: After 8 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    To compare the difference of sitting DBP between fimasaratn 30mg group and valsartan 80mg group

  • the difference of SiDBP [ Time Frame: After 4 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    To compare the difference of SiDBP among fimasartan 30mg group, valsartan 80mg and placebo group

  • the difference of SiSBP [ Time Frame: After 4 weeks and 8 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    To compare the difference of SiSBP among fimasartan 30mg group, valsartan 80mg and placebo group

  • the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg) [ Time Frame: After 8 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    To compare the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group

  • the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg & SiSBP<140mmHg) [ Time Frame: After 8 weeks from baseline visit ] [ Designated as safety issue: Yes ]
    To compare the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg & SiSBP<140mmHg) among fimasartan 30mg group, valsartan 80mg and placebo group


Estimated Enrollment: 275
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
1 capsule/day of placebo will be orall administered for the study period (8 weeks)
Drug: Placebo
Placebo
Other Name: Placebo
Active Comparator: Valsartan 80mg
(As reference group) 80mg/day of Valsartan will be orall administered for the study period (8 weeks)
Drug: Valsartan
Valsartan 80mg
Other Name: Diovan
Experimental: Fimasartan 30mg
30mg/day of Fimasartan will be orall administered for the study period (8 weeks)
Drug: Fimasartan
Fimasartan 30mg
Other Name: Kanarb

Detailed Description:

After subjects have signed informed consent voluntarily, when they are taking hypertension medication, they go through screening period for 7 days including wash-out period.

After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days), and evaluate their suitability to Inclusion and Exclusion criteria.

Patients, who evaluated the proper subject for this clinical trial, are allocated to experimental group (Fimasartan 30mg) or Control group (Placebo group) or Reference group (Valsartan 80mg) randomly at a ratio 2:2:1 and their investigational drugs will be administered daily for the study period (8 weeks). Subjects visit their investigators twice during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.

The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjecs who agreed to participate in this clinical trial and submitted the written informed consent
  2. Subjects aged 20 to 75 years
  3. Essential hypertension patients who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure(SiDBP) at baseline(Day 0)
  4. Subject who considered to understand this clinical trial, be cooperative,and able to be followed-up whole of the clinical trial period

Exclusion Criteria:

  1. Severe hypertension patients: more 110mmHg of mean SiDBP and/or more 185mmHg of mean Sitting systolic blood pressure(SiSBP)
  2. Patients with orthostatic hypotension who has sign and symptom
  3. Patients with secondary hypertension
  4. Patients who are measured the difference of mean blood pressure of one arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
  5. Patients who cannot stop administration of hypertension medication through the clinical trial period, and can take any other hypertension medication except investigational drugs
  6. Patients with significant investigations-abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function(AST, ALT more 2 times than upper limit of normal), severe fatty liver disease needed medication
  7. Patients with clinically significant investigations in laboratory test of screening visit
  8. Patients with surgical and medical disease that is able to be affect to absorption, distribution, metabolism and excretion
  9. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c>9, regimen change of oral hypoglycemic agent, using insulin)
  10. Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous transluminal coronary angiography(PTCA), Coronary artery bypass graft(CABG)
  11. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
  12. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
  13. Patients with severe cerebrovascular disease
  14. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous
  15. Patients with known severe or malignancy retinopathy
  16. Patients with hepatitis B or C or HIV positive reaction
  17. Patients with the medical histories of malignant tumor within 5 years,except local basal cell carcinoma of the skin
  18. Patients who have a story or evidence of alcohol or drug abuse within 2 years
  19. Patients with history of allergic reaction to any angiotensin II antagonist
  20. Patients with any chronic inflammation disease needed to chronic inflammation therapy
  21. Childbearing and breast-feeding women
  22. Femal who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
  23. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
  24. Patients with significant investigations-Hypokalemia(Less than 3.5 mmol/L), Hyperkalemia(exceeded 5.5 mmol/L)
  25. Patients with sodium ion or body fluid is deplated and not able to correct
  26. Subject who are judged unsuitable to participate in this clinical trial by investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672476

Contacts
Contact: Seong Hee Lee, Director 82-2-708-8069 shlee07@boryung.co.kr
Contact: So Jin Kim, Project Manager 82-2-740-4341 kimsojin@boryung.co.kr

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seok-min Kang, M.D., Ph.D.         
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
The Catholic University of Korea
Konyang University Hospital
Korea University
Ilsan Hospital
Daegu Fatima Hospital
Dong-A University
Soon Chun Hyang University
Asan Medical Center
Gangnam Severance Hospital
Severance Hospital
Ulsan University Hospital
Eulji University Hospital
Kangbuk Samsung Hospital
Sejong General Hospital
Ewha Womans University Mokdong Hospital
Jeju National University Hospital
Hallym University Medical Center
Hanyang University
Investigators
Principal Investigator: Seok Min Kang, M.D., Ph.D. Severance Hospital
  More Information

No publications provided

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01672476     History of Changes
Other Study ID Numbers: A657-BR-CT-L301
Study First Received: August 20, 2012
Last Updated: September 4, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan

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 August 19, 2014