Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients

NCT00922480 | Completed Phase 3 Results DMC

• 1 other identifier: A657-BR-CT-301
• Study Type: interventional
• Target: 506
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) 60 mg\~120 mg in patients with mild to moderate essential hypertension.

Conditions

Hypertension

Keywords

Hypertension; Losartan

Outcome Measures

Primary Outcomes (1)

• Diastolic Blood Pressure Change

  Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position

  baseline and 12 weeks

Secondary Outcomes (1)

• Diastolic Blood Pressure Change

  baseline and 4 weeks, 8 weeks

Study Arms (2)

2

ACTIVE COMPARATOR

Losartan group

Drug: Losartan (Control)

1

ACTIVE COMPARATOR

Fimasartan 60mg, 120mg

Drug: Fimasartan

Interventions

Fimasartan DRUG

Fimasartan 60 \~ 120mg/po take one tablets once a day

Also known as: A657-BR-CT

1

Losartan (Control) DRUG

Losartan 50 mg \~ 100 mg/po, take one tablets once a day

Also known as: Cozar

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 1.5 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Seoul National University Hospital: collaborator
• The Catholic University of Korea: collaborator
• Kangbuk Samsung Hospital: collaborator
• Konkuk University Medical Center: collaborator
• Konyang University Hospital: collaborator
• Keimyung University: collaborator
• Korea University: collaborator
• Korea University Guro Hospital: collaborator
• Dongguk University International Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator
• Severance Hospital: collaborator
• Ajou University: collaborator
• Wonju Severance Christian Hospital: collaborator
• Yeungnam University Hospital: collaborator
• Yonsei University: collaborator
• Inha University Hospital: collaborator
• Chonbuk National University Hospital: collaborator
• Cheil General Hospital and Women's Healthcare Center: collaborator
• Chungnam National University: collaborator
• Chungbuk National University Hospital: collaborator
• Hanyang University: collaborator

Related Publications (2)

• Lee SE, Kim YJ, Lee HY, Yang HM, Park CG, Kim JJ, Kim SK, Rhee MY, Oh BH; Investigators. Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan (50/100 mg): a 12-week, phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension. Clin Ther. 2012 Mar;34(3):552-568, 568.e1-9. doi: 10.1016/j.clinthera.2012.01.024. Epub 2012 Mar 3.

  PMID: 22381711 DERIVED

• Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.

  PMID: 21740078 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Manager of Clinical Research
• Organization: Boryung Pharmaceuticals

rainbowleo@boryung.co.kr

+82-2-708-8069

Study Officials

• Byung-Hee Oh, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 10, 2018
• Results First Posted: February 13, 2018

Record last verified: 2018-03