Clinical trial NCT01672476: A Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension
Official title: A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Fimasartan
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Bucheon St. Mary's Hospital
name: Konyang University Hospital
name: Korea University Anam Hospital
name: National Health Insurance Service Ilsan Hospital
name: Daegu Fatima Hospital
name: Dong-A University
name: Soon Chun Hyang University
name: Asan Medical Center
name: Gangnam Severance Hospital
name: Severance Hospital
name: Ulsan University Hospital
name: Kangbuk Samsung Hospital
name: Sejong General Hospital
name: Ewha Womans University Mokdong Hospital
name: Jeju National University Hospital
name: Hallym University Medical Center
name: Hanyang University
First posted: 2012-08-27
Enrollment: 293
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild to Moderate Essential Hypertension

Detailed description: After subjects have signed informed consent voluntarily, when they are taking hypertension medication, they go through screening period for 7 days including wash-out period.

After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days), and evaluate their suitability to Inclusion and Exclusion criteria.

Patients, who evaluated the proper subject for this clinical trial, are allocated to experimental group (Fimasartan 30mg) or Control group (Placebo group) or Reference group (Valsartan 80mg) randomly at a ratio 2:2:1 and their investigational drugs will be administered daily for the study period (8 weeks). Subjects visit their investigators twice during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.

The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.

Eligibility criteria: Inclusion Criteria:

1. Subjects who agreed to participate in this clinical trial and submitted the written informed consent
2. Subjects aged 20 to 75 years
3. Essential hypertension patients who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure(SiDBP) at baseline(Day 0)
4. Subject who considered to understand this clinical trial, be cooperative,and able to be followed-up whole of the clinical trial period

Exclusion Criteria:

1. Severe hypertension patients: more 110mmHg of mean SiDBP and/or more 185mmHg of mean Sitting systolic blood pressure(SiSBP)
2. Patients with orthostatic hypotension who has sign and symptom
3. Patients with secondary hypertension
4. Patients who are measured the difference of mean blood pressure of one arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
5. Patients who cannot stop administration of hypertension medication through the clinical trial period, and can take any other hypertension medication except investigational drugs
6. 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 limit of normal), severe fatty liver disease needed medication
7. Patients with clinically significant investigations in laboratory test of screening visit
8. Patients with surgical and medical disease that is able to be affect to absorption, distribution, metabolism and excretion
9. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c\>9, regimen change of oral hypoglycemic agent, using insulin)
10. Patients with severe heart disease, ischemic heart disease within 6 months, peripheral vascular disease, Percutaneous transluminal coronary angiography(PTCA), Coronary artery bypass graft(CABG)
11. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
12. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
13. Patients with severe cerebrovascular disease
14. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous
15. Patients with known severe or malignancy retinopathy
16. Patients with hepatitis B or C or HIV positive reaction
17. Patients with the medical histories of malignant tumor within 5 years,except local basal cell carcinoma of the skin
18. Patients who have a story or evidence of alcohol or drug abuse within 2 years
19. Patients with history of allergic reaction to any angiotensin II antagonist
20. Patients with any chronic inflammation disease needed to chronic inflammation therapy
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. Patients with significant investigations-Hypokalemia(Less than 3.5 mmol/L), Hyperkalemia(exceeded 5.5 mmol/L)
25. Patients with sodium ion or body fluid is deplated and not able to correct
26. Subject who are judged unsuitable to participate in this clinical trial by investigator

Primary outcomes:
measure: the difference of sitting DBP
timeFrame: After 8 weeks from baseline visit
Secondary outcomes:
measure: the difference of sitting DBP
timeFrame: After 8 weeks from baseline visit
measure: the difference of SiDBP
timeFrame: After 4 weeks from baseline visit
measure: the difference of SiSBP
timeFrame: After 4 weeks and 8 weeks from baseline visit
measure: the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg)
timeFrame: After 8 weeks from baseline visit
measure: the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg & SiSBP<140mmHg)
timeFrame: After 8 weeks from baseline visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Seok Min Kang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Youn JC, Ihm SH, Bae JH, Park SM, Jeon DW, Jung BC, Park TH, Lee NH, Song JM, Yoon YW, Shin ES, Sung KC, Jung IH, Pyun WB, Joo SJ, Park WJ, Shin JH, Kang SM. Efficacy and safety of 30-mg fimasartan for the treatment of patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, phase III clinical study. Clin Ther. 2014 Oct 1;36(10):1412-21. doi: 10.1016/j.clinthera.2014.07.004. Epub 2014 Aug 3.