Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion (STIFFNESS)

A Single-arm, Open, Clinical Study to Evaluate the Effects of Fimasartan on Arterial Stiffness in Patients With Hypertension

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Fimasartan

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of, 501-757
    • Chonnam National University Hospital
  • Gwangju, Korea, Republic of
    • Gwagnju Christian Hospital
  • Gwangju, Korea, Republic of
    • Gwanju Veterans Hospital
  • Iksan, Korea, Republic of
    • Wonkwang University Hospital
  • Jeonju, Korea, Republic of
    • Jeonbuk National University Hospital
  • Jeonju, Korea, Republic of
    • Jeonju Jesus Hospital
  • Jeollanamdo
    • Suncheon, Jeollanamdo, Korea, Republic of
      • St. Carollo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Multiple secondary and tertiary centers

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of carotid radial strain value	Improvement of carotid arterial stiffness measured by echocardiography	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Improvement in central blood pressure (BP)	24 weeks

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Kye Hun Kim, MD, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 22, 2013
• First Posted (Estimated): December 30, 2013

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CN-KKH-01