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

NCT00922441 | Completed Phase 2 Results DMC

• 1 other identifier: A657-BR-CT-203
• Study Type: interventional
• Target: 92
• 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) during 24 hours by dose in patients with mild to moderate essential hypertension.

Conditions

Essential Hypertension

Keywords

Fimasartan; Essential Hypertension; 24hour ABPM; Population PK

Outcome Measures

Primary Outcomes (1)

• Mean Change of Diastolic Blood Pressure

  24hr Mean change of DBP on Week 8, from Baseline

  baseline and 8 Weeks

Study Arms (3)

Fimasartan 1

EXPERIMENTAL

Fimasartan 60 mg group

Drug: Fimasartan 60 mg group

Fimasartan 2

EXPERIMENTAL

Fimasartan 120 mg group

Drug: Fimasartan 120 mg group

Valsartan

ACTIVE COMPARATOR

Reference (Valsartan 80 mg) group

Drug: Reference (Valsartan 80 mg) group

Interventions

Fimasartan 60 mg group DRUG

Fimasartan 60 mg

Also known as: BR-A-657.K

Fimasartan 1

Fimasartan 120 mg group DRUG

Fimasartan 120 mg

Also known as: BR-A-657.K

Fimasartan 2

Reference (Valsartan 80 mg) group DRUG

Reference (Valsartan 80 mg)

Also known as: Diovan

Valsartan

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 1.5mg/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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Seoul National University Hospital: collaborator
• Kyungpook National University Hospital: collaborator
• Catholic Medical Center: collaborator
• Inje University: collaborator
• Chonnam National University Hospital: collaborator

Related Publications (1)

• Lee H, Kim KS, Chae SC, Jeong MH, Kim DS, Oh BH. Ambulatory blood pressure response to once-daily fimasartan: an 8-week, multicenter, randomized, double-blind, active-comparator, parallel-group study in Korean patients with mild to moderate essential hypertension. Clin Ther. 2013 Sep;35(9):1337-49. doi: 10.1016/j.clinthera.2013.06.021. Epub 2013 Aug 7.

  PMID: 23932463 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan; Population Groups; Valsartan

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

rainbowleo@boryung.co.kr

+82-2-708-8069

Study Officials

• Byung-He Oh, Professor

  Seoul National University Hospital

  STUDY CHAIR

• Dong-Soo Kim, Professor

  Inje University

  PRINCIPAL INVESTIGATOR

• Sung Chul Chae, Professor

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

• Gi-Sik Kim, professor

  Daegu Catholic University Medical Center

  PRINCIPAL INVESTIGATOR

• Myung-Ho Jung, Professor

  Connam National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 15, 2018
• Results First Posted: February 13, 2018

Record last verified: 2018-02