Status:
COMPLETED
Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsors:
Seoul National University Hospital
Samsung Medical Center
Conditions:
Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8 week treatment with Fimasartan (BR-A-657-K) 20, 60, 120, 240 mg and placebo in patients with mild to modera...
Detailed Description
Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20mg \~ 48...
Eligibility Criteria
Inclusion
- Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Screening and Baseline(Day1) are 95\~114 mmHg inclusive and the difference between sitting diastolic blood pressures measured at Day -14 and Baseline(Day1) is under 7mmHg.
- Subjects who agree to participate in this sudy and give written informed consent
- Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
Exclusion
- The sitting DBP is less than 94mmHg or more than 115mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg
- Patients with secondary hypertension
- Patients with severe renal(Creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
- Patients with postural hypotension
- Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c\>9%, regimen change of oral hypoglycemic agents within 3 months, treated insulin before screening)
- Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
- Patients with consumptive disease, autoimmune disease, connective tissue disease
- Patients with a history of type B or C hepatitis
- Patients with HIV or hepatitis
- Patients with clinically significant laboratory abnormality
- Patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure
- Patients with allergy or contraindication to any angiotensin II receptor antagonists
- Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
- Patients judged to have a history of alcohol or drug abuse by the investigator
- Patients with average weight \> +35% or \<-15% in Modified Metropolitan Life Insurance table
- Patients participated other clinical trial 3 months before Screening
- Patients judged to be inappropriate for this study by the investigator with other reasons
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00923611
Start Date
September 1 2007
End Date
June 1 2008
Last Update
June 18 2009
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea