Clinical trial NCT01135212: The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension
Official title: A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension (Phase IIIb)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
ARB
Fimasartan
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kyungpook National University Hospital
name: Gyeongsang National University Hospital
name: Keimyung University
name: Kosin University Gospel Hospital
name: Daegu Catholic University Medical Center
name: Dong-A medical center
name: Pusan National University Yangsan Hospital
name: Yeungnam University Hospital
name: Ulsan University Hospital
name: Inje University
name: Pusan National University Hospital
First posted: 2010-06-02
Enrollment: 290
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.

Detailed description: A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit.

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).

Eligibility criteria: Inclusion Criteria:

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

1. Severe hypertension patients; more 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)
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

Primary outcomes:
measure: Sitting Diastolic Blood Pressure
timeFrame: 12weeks from baseline visit
Secondary outcomes:
measure: Sitting DBP
timeFrame: at 12weeks from Baseline visit
measure: SittingDBP
timeFrame: at 4, 8 weeks from baseline visit
measure: Sitting Systolic Blood Pressure
timeFrame: at 4,8,12 weeks from baseline visit
measure: Responder ratio
timeFrame: at 12weeks from baseline visit
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: KyungPook National University Hospital
Study officials:
affiliation: KuyngPook National Hospital
name: ShungChull Chae, Doctor´s degree
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.