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

NCT01672476 | Completed Phase 3 DMC

• 1 other identifier: A657-BR-CT-L301
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

Fimasartan

Outcome Measures

Primary Outcomes (1)

• the difference of sitting DBP

  To compare the difference of sitting DBP between fimasartan 30mg group and placebo group

  After 8 weeks from baseline visit

Secondary Outcomes (5)

• the difference of sitting DBP

  After 8 weeks from baseline visit

• the difference of SiDBP

  After 4 weeks from baseline visit

• the difference of SiSBP

  After 4 weeks and 8 weeks from baseline visit

• the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg)

  After 8 weeks from baseline visit

• the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg & SiSBP<140mmHg)

  After 8 weeks from baseline visit

Study Arms (3)

Placebo

PLACEBO COMPARATOR

1 capsule/day of placebo will be orally administered for the study period (8 weeks)

Drug: Placebo

Valsartan 80mg

ACTIVE COMPARATOR

(As reference group) 80mg/day of Valsartan will be orally administered for the study period (8 weeks)

Drug: Valsartan

Fimasartan 30mg

EXPERIMENTAL

30mg/day of Fimasartan will be orally administered for the study period (8 weeks)

Drug: Fimasartan

Interventions

Placebo DRUG

Placebo

Placebo

Valsartan DRUG

Valsartan 80mg

Also known as: Diovan

Valsartan 80mg

Fimasartan DRUG

Fimasartan 30mg

Also known as: Kanarb

Fimasartan 30mg

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe hypertension patients: more 110mmHg of mean SiDBP and/or more 185mmHg of mean Sitting systolic blood pressure(SiSBP)
• Patients with orthostatic hypotension who has sign and symptom
• Patients with secondary hypertension
• Patients who are measured the difference of mean blood pressure of one arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
• Patients who cannot stop administration of hypertension medication through the clinical trial period, and can take any other hypertension medication except investigational drugs
• 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
• Patients with clinically significant investigations in laboratory test of screening visit
• Patients with surgical and medical disease that is able to be affect to absorption, distribution, metabolism and excretion
• Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c\>9, regimen change of oral hypoglycemic agent, using insulin)
• Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous transluminal coronary angiography(PTCA), Coronary artery bypass graft(CABG)
• Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
• Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
• Patients with severe cerebrovascular disease
• Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous
• Patients with known severe or malignancy retinopathy

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Bucheon St. Mary's Hospital: collaborator
• Konyang University Hospital: collaborator
• Korea University Anam Hospital: collaborator
• National Health Insurance Service Ilsan Hospital: collaborator
• Daegu Fatima Hospital: collaborator
• Dong-A University: collaborator
• Soon Chun Hyang University: collaborator
• Asan Medical Center: collaborator
• Gangnam Severance Hospital: collaborator
• Severance Hospital: collaborator
• Ulsan University Hospital: collaborator
• Kangbuk Samsung Hospital: collaborator
• Sejong General Hospital: collaborator
• Ewha Womans University Mokdong Hospital: collaborator
• Jeju National University Hospital: collaborator
• Hallym University Medical Center: collaborator
• Hanyang University: collaborator

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• Youn JC, Ihm SH, Bae JH, Park SM, Jeon DW, Jung BC, Park TH, Lee NH, Song JM, Yoon YW, Shin ES, Sung KC, Jung IH, Pyun WB, Joo SJ, Park WJ, Shin JH, Kang SM. Efficacy and safety of 30-mg fimasartan for the treatment of patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, phase III clinical study. Clin Ther. 2014 Oct 1;36(10):1412-21. doi: 10.1016/j.clinthera.2014.07.004. Epub 2014 Aug 3.

  PMID: 25092393 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; fimasartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Seok Min Kang, M.D., Ph.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 27, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

KR (1)