Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion

NCT02022774 | Completed DMC

• 1 other identifier: CN-KKH-01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Improvement of carotid radial strain value

  Improvement of carotid arterial stiffness measured by echocardiography

  24 weeks

Secondary Outcomes (6)

• Improvement in brachial-ankle pulse wave velocity (baPWV)

  24 weeks

• Improvement in augmentation index (AIx)

  24 weeks

• Improvement in carotid distensibility

  24 weeks

• Improvement in sitting systolic blood pressure (SiSBP)

  24 weeks

• Improvement in sitting diastolic blood pressure (SiDBP)

  24 weeks

Interventions

Fimasartan DRUG

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

Also known as: BR-A-657-K

Eligibility Criteria

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

Study Population

Multiple secondary and tertiary centers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (7)

St. Carollo Hospital

Suncheon, Jeollanamdo, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Gwagnju Christian Hospital

Gwangju, South Korea

Location

Gwanju Veterans Hospital

Gwangju, South Korea

Location

Wonkwang University Hospital

Iksan, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Jeonju Jesus Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kye Hun Kim, MD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 30, 2013
• Study Start: April 1, 2012
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

KR (7)