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
Information source: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Fimasartan , Amlodipine, Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Boryung Pharmaceutical Co., Ltd Official(s) and/or principal investigator(s): Young Kwan Jeon, Medical Director, Study Director, Affiliation: Boryung Pharmaceutical Co., Ltd
Overall contact: Sung Hee Lee, Manager, Phone: 82-2-708-8069, Email: shlee07@boryung.co.kr
Summary
The purpose of this study is to evaluate the antihypertensive efficacy and safety of
Fimasartan
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Sitting Diastolic Blood Pressure
Secondary outcome: Sitting Systolic Blood PressureSitting Diastolic Blood Pressure Responder ratio
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Sung Hee Lee, Manager, Phone: 82-2-708-8069, Email: shlee07@boryung.co.kr
Samsung Medical Center, Seoul, Korea, Republic of; Recruiting Eun Seok Jeon, Phone: 82-2-3410-0866, Email: esjeon@smc.co.kr
Additional Information
Starting date: August 2011
Last updated: March 26, 2013
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