A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension
NCT ID: NCT01518998
Last Updated: 2016-07-01
Study Results
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Basic Information
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COMPLETED
PHASE2
420 participants
INTERVENTIONAL
2011-08-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Placebo
Take one double-blind capsule filled with a placebo tablet in the every morning
Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Fimasartan 60mg
Take one double-blind capsule filled with of Fimasartan 60mg in the every morning
Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Fimasartan 30mg
Take one double-blind capsule filled with Fimasartan 30mg in the every morning
Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Amlodipine 5mg
Take one double-blind capsule filled with Amlodipine 5mg in the every morning
Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Amlodipine 10mg
Take one double-blind capsule filled with Amlodipine 10mg in the every morning
Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Fimasartan 60mg/ Amlodipine 5mg
Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning
Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Fimasartan 60mg/Amlodipine 10mg
Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning
Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Fimasartan 30mg/Amlodipine 5mg
Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning
Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Fimasartan 30mg/Amlodipine 10mg
Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning
Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Interventions
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Fimasartan , Amlodipine, Placebo
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects aged 20 to 75 years
3. Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg 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 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
4. Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
5. Patients with sodium ion or body fluid is depleted and not able to correct
6. Patients with hypotension who has sign and symptom
7. Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
8. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c \> 9%, regimen change of oral hypoglycemic agent, using insulin)
9. Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
10. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
11. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
12. Patients with severe cerebrovascular disease
13. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
14. Patients with known severe or malignancy retinopathy
15. Patients with hepatitis B or C or HIV positive reaction
16. Patients who have a story or evidence of alcohol or drug abuse within 2years
17. 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
18. Patients with history of allergic reaction to any angiotensin II antagonist
19. Patients with any chronic inflammation disease needed to chronic inflammation therapy
20. Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
21. Childbearing and breast-feeding women
22. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
23. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
24. Subject who are judged unsuitable to participate in this study by investigator
20 Years
75 Years
ALL
No
Sponsors
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Gachon University Gil Medical Center
OTHER
The Catholic University of Korea
OTHER
Kyungpook National University Hospital
OTHER
Daegu Catholic University Medical Center
OTHER
Wonkwang University Hospital
OTHER
Wonju Severance Christian Hospital
OTHER
Korea University Guro Hospital
OTHER
DongGuk University
OTHER
Yeungnam University Hospital
OTHER
Chonnam National University Hospital
OTHER
Cheil General Hospital and Women's Healthcare Center
OTHER
Chungnam National University
OTHER
Asan Medical Center
OTHER
Seoul National University Bundang Hospital
OTHER
Inha University Hospital
OTHER
Seoul National University Hospital
OTHER
Inje University
OTHER
Samsung Medical Center
OTHER
Busan National University Yangsan Hospital
UNKNOWN
Soon Chun Hyang University
OTHER
Catholic University of Korea Saint Paul's Hospital
OTHER
Hallym University Kangnam Sacred Heart Hospital
OTHER
Jeju National University Hospital
OTHER
Hanyang University Seoul Hospital
OTHER
Kangbuk Samsung Hospital
OTHER
Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Young Kwan Jeon, Medical Director
Role: STUDY_DIRECTOR
Boryung Pharmaceutical Co., Ltd
Locations
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Samsung Medical Center
Seoul, Seoul, South Korea
Countries
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References
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Lee HY, Kim YJ, Ahn T, Youn HJ, Chull Chae S, Seog Seo H, Kim KS, Rhee MY, Choi DJ, Kim JJ, Chun KJ, Yoo BS, Park JS, Oh SK, Kim DS, Kwan J, Ahn Y, Bae Park J, Jeong JO, Hyon MS, Cho EJ, Han KR, Kim DI, Joo SJ, Shin JH, Sung KC, Jeon ES. A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 x 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension. Clin Ther. 2015 Nov 1;37(11):2581-2596.e3. doi: 10.1016/j.clinthera.2015.02.019. Epub 2015 Apr 4.
Other Identifiers
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BR-FAC-CT-201
Identifier Type: -
Identifier Source: org_study_id
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