Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion

NCT ID: NCT02022774

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2017-06-30

Brief Summary

The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension

Conditions

Hypertension

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Fimasartan

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

Intervention Type: DRUG

Other Intervention Names

BR-A-657-K

Eligibility Criteria

Inclusion Criteria

• Subjects who agree to participate in this study and give written informed consent
• Subjects whose sitting diastolic blood pressure measured at placebo visit and baseline are more than 90 mmHg and/or systolic blood pressure are more than 140 mmHg
• Subjects who are naive to anti-hypertensive treatment
• Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study

Exclusion Criteria

• Subjects who are hypersensitive to angiotensin type 1-receptor blockers
• Subjects with secondary hypertension
• Subjects with severe hypertension (systolic blood pressure >= 180 mmHg OR diastolic blood pressure >= 110)
• Severe cardiac disease (heart failure, ischemic heart disease, peripheral vascular disease, moderate valvular disease, arrhythmia requiring treatment, cardiomyopathy, etc.)
• Subjects with chronic obstructive pulmonary disease or history
• Clinically significant renal dysfunction (Creatinine 2.0 mg/dL) and liver dysfunction (ALT, AST > 2x UNL)
• Subjects with life expectancy of less than 2 years due to non-cardiac disease
• Subjects with history or evidence of abuse of drugs or alcohol within 2 years
• Severe insulin-dependent diabetes mellitus or intractable diabetic patient (dose/regimen change of oral hypoglycemic agent, insulin use)
• Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, within 6 months)
• Wasting diseases, autoimmune diseases (rheumatoid arthritis, systemic lupus anticoagulants, etc.), history of connective tissue disease or ongoing disease.
• Women with pregnancy and breast feeding
• Women planning to be pregnant or without admitted contraception despite of probability of pregnancy (Women who underwent sterilization operation are excluded. Fertile women without such surgery should undergo pregnancy test and can participate only with negative result. Intermittent abstinence like basic body temperature method, natural period method are not considered admitted contraception and no hormonal contraception is allowed.).
• Subjects who are participating in other clinical trials for investigating agents or have taken other clinical trial medication within 4 weeks before screening visit.
• Subjects judged to be inappropriate by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kye Hun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Locations

St. Carollo Hospital

Suncheon, Jeollanamdo, South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Gwagnju Christian Hospital

Gwangju, , South Korea

Gwanju Veterans Hospital

Gwangju, , South Korea

Wonkwang University Hospital

Iksan, , South Korea

Jeonbuk National University Hospital

Jeonju, , South Korea

Jeonju Jesus Hospital

Jeonju, , South Korea

Countries

South Korea

Other Identifiers

CN-KKH-01

Identifier Type: -

Identifier Source: org_study_id