The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension
NCT ID: NCT01135212
Last Updated: 2012-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
290 participants
INTERVENTIONAL
2010-04-30
2011-05-31
Brief Summary
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Detailed Description
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During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fimasartan 60mg
Take one tablet of Fimasartan 60mg once a day in the morning
Fimasartan 60mg
Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Fimasartan 120mg
Take one tablet of Fimasartan 120mg once a day in the morning
Fimasartan 120mg
Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Candesartan 8mg
Take one tablet of Candesartan 8mg once a day in the morning
Candesartan cilexetil
Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Interventions
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Fimasartan 60mg
Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Fimasartan 120mg
Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Candesartan cilexetil
Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects aged 19 to 75 years
3. Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
4. Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.
Exclusion Criteria
2. Patients with secondary hypertension
3. Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
4. Patients with hypotension who has sign and symptom
5. Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
6. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c \> 9%, regimen change of oral hypoglycemic agent, using insulin)
7. Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
8. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
9. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
10. Patients with severe cerebrovascular disease
11. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
12. Patients with known severe or malignancy retinopathy
13. Patients with hepatitis B or C or HIV positive reaction
14. Patients who have a story or evidence of alcohol or drug abuse within 2years
15. Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
16. Patients with history of allergic reaction to any angiotensin II antagonist
17. Patients with any chronic inflammation disease needed to chronic inflammation therapy
18. Childbearing and breast-feeding women
19. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
20. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
21. Subject who are judged unsuitable to participate in this study by investigator
19 Years
75 Years
ALL
No
Sponsors
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Kyungpook National University Hospital
OTHER
Gyeongsang National University Hospital
OTHER
Keimyung University
OTHER
Kosin University Gospel Hospital
OTHER
Daegu Catholic University Medical Center
OTHER
Dong-A medical center
UNKNOWN
Pusan National University Yangsan Hospital
OTHER
Yeungnam University Hospital
OTHER
Ulsan University Hospital
OTHER
Inje University
OTHER
Pusan National University Hospital
OTHER
Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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ShungChull Chae, Doctor´s degree
Role: PRINCIPAL_INVESTIGATOR
KuyngPook National Hospital
Locations
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KyungPook National University Hospital
Daegu, Daegu, South Korea
Countries
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References
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Lee JH, Yang DH, Hwang JY, Hur SH, Cha TJ, Kim KS, Kim MH, Chun KJ, Cha GS, Hong GR, Lee SG, Kim DS, Kim DI, Chae SC. A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients with Mild to Moderate Essential Hypertension. Clin Ther. 2016 Jun;38(6):1485-1497. doi: 10.1016/j.clinthera.2016.04.005. Epub 2016 May 6.
Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.
Other Identifiers
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A657-BR-CT-302
Identifier Type: -
Identifier Source: org_study_id