Status:
COMPLETED
Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Study objective: 1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the oral administration of BR-A-657•K at 20\~180mg for 4 weeks to patients with essential hype...
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
- Adult men and women, aged 18 - 65
- Patients with mild to moderate essential hypertension: On both screening and Day -1 visit, mean sitting DBP should be ≥ 95mmHg and ≤ 114mmHg, and ΔDBP on Day -14 and Day -1 should be within 7 mmHg
- Patients who gave their consent to participate in this study and signed the written informed consent form
- Patients who have understood the study, and been judged to be cooperative and able to participate in the study until the study completion date
Exclusion
- Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures.
- Patients whose sitting DBP is \< 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg
- Patients with secondary hypertension
- Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs
- Patients with symptoms of orthostatic hypotension
- Patients with severe insulin dependent diabetes or uncontrolled diabetes
- Patients who suffered myocardial infarction or serious coronary arterial disease over the past 6 months or patients with clinically significant congestive heart failure or valvular heart disease
- Patients with consumption disease, autoimmune disease, or connective tissue disease
- Patients with the history of type B hepatitis or type C hepatitis
- Patients with HIV infection or hepatitis
- Patients with clinically significant abnormal laboratory test findings
- Patients on any drug treatment that might affect the blood pressure
- Patients with allergy or contraindication to angiotensin II-receptor antagonists
- Patients with current or suspected alcohol addiction or history of drug abuse
- Patients whose mean weight lies out of the range of -15% \~ +35%, based on the Modified Metropolitan Life Insurance table
- Patients who are not eligible as subjects of the study, as determined by the principal investigator or a sub-investigator
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00937651
Start Date
April 1 2005
End Date
June 1 2006
Last Update
July 13 2009
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