Clinical trial NCT01518998: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Fimasartan
Amlodipine
antihypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Gachon University Gil Medical Center
name: The Catholic University of Korea
name: Kyungpook National University Hospital
name: Daegu Catholic University Medical Center
name: Wonkwang University Hospital
name: Wonju Severance Christian Hospital
name: Korea University Guro Hospital
name: DongGuk University
name: Yeungnam University Hospital
name: Chonnam National University Hospital
name: Cheil General Hospital and Women's Healthcare Center
name: Chungnam National University
name: Asan Medical Center
name: Seoul National University Bundang Hospital
name: Inha University Hospital
name: Seoul National University Hospital
name: Inje University
name: Samsung Medical Center
name: Busan National University Yangsan Hospital
name: Soon Chun Hyang University
name: Catholic University of Korea Saint Paul's Hospital
name: Hallym University Kangnam Sacred Heart Hospital
name: Jeju National University Hospital
name: Hanyang University Seoul Hospital
name: Kangbuk Samsung Hospital
First posted: 2012-01-26
Enrollment: 420
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan


Eligibility criteria: Inclusion Criteria:

1. Subjects who agreed to participate in this study and submitted the written informed consent
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:

1. Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)
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

Primary outcomes:
measure: Sitting Diastolic Blood Pressure
timeFrame: 8weeks from baseline visit
Secondary outcomes:
measure: Sitting Systolic Blood Pressure
timeFrame: at 4 and 8 weeks from Baseline visit
measure: Sitting Diastolic Blood Pressure
timeFrame: 4weeks from baseline visit
measure: Responder ratio
timeFrame: at 8weeks from baseline visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Boryung Pharmaceutical Co., Ltd
name: Young Kwan Jeon, Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.