Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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 moderate essential hypertension and to determine the adequate antihypertensive dosage for later clinical study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Asan Medical Center; Cheil General Hospital and Women's Healthcare Center; Cheil General Hospital and Women’s Healthcare Center; Samsung Medical Center; Seoul National University Bundang Hospital; Seoul National University Hospital; Severance Hospital; The Catholic University of Korea; Yonsei University
• Treatments: Antihypertensive Agents

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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