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STIFFNESS: Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion

Sponsor
Boryung Pharmaceutical Co., Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02022774
Collaborator
(none)
90
Enrollment
7
Locations
12.9
Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Single-arm, Open, Clinical Study to Evaluate the Effects of Fimasartan on Arterial Stiffness in Patients With Hypertension
Study Start Date :
Apr 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2016

Outcome Measures

Primary Outcome Measures

  1. Improvement of carotid radial strain value [24 weeks]

    Improvement of carotid arterial stiffness measured by echocardiography

Secondary Outcome Measures

  1. Improvement in brachial-ankle pulse wave velocity (baPWV) [24 weeks]

  2. Improvement in augmentation index (AIx) [24 weeks]

  3. Improvement in carotid distensibility [24 weeks]

  4. Improvement in sitting systolic blood pressure (SiSBP) [24 weeks]

  5. Improvement in sitting diastolic blood pressure (SiDBP) [24 weeks]

  6. Improvement in central blood pressure (BP) [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Carollo Hospital Suncheon Jeollanamdo Korea, Republic of
2 Chonnam National University Hospital Gwangju Korea, Republic of 501-757
3 Gwagnju Christian Hospital Gwangju Korea, Republic of
4 Gwanju Veterans Hospital Gwangju Korea, Republic of
5 Wonkwang University Hospital Iksan Korea, Republic of
6 Jeonbuk National University Hospital Jeonju Korea, Republic of
7 Jeonju Jesus Hospital Jeonju Korea, Republic of

Sponsors and Collaborators

  • Boryung Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Kye Hun Kim, MD, Chonnam National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT02022774
Other Study ID Numbers:
  • CN-KKH-01
First Posted:
Dec 30, 2013
Last Update Posted:
Sep 22, 2016
Last Verified:
Sep 1, 2016
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Sep 22, 2016