Clinical trial NCT02022774: Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion
Official title: A Single-arm, Open, Clinical Study to Evaluate the Effects of Fimasartan on Arterial Stiffness in Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple secondary and tertiary centers

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


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

Primary outcomes:
measure: Improvement of carotid radial strain value
timeFrame: 24 weeks
Secondary outcomes:
measure: Improvement in brachial-ankle pulse wave velocity (baPWV)
timeFrame: 24 weeks
measure: Improvement in augmentation index (AIx)
timeFrame: 24 weeks
measure: Improvement in carotid distensibility
timeFrame: 24 weeks
measure: Improvement in sitting systolic blood pressure (SiSBP)
timeFrame: 24 weeks
measure: Improvement in sitting diastolic blood pressure (SiDBP)
timeFrame: 24 weeks
measure: Improvement in central blood pressure (BP)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Suncheon
country: Korea, Republic of
facility: St. Carollo Hospital
state: Jeollanamdo
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Gwagnju Christian Hospital
city: Gwangju
country: Korea, Republic of
facility: Gwanju Veterans Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonju Jesus Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Kye Hun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: