Phase 3
Completed N=505
Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients
Source: ClinicalTrials.gov NCT00922480 ↗Enrolled (actual)
505
Serious AEs
1.6%
Results posted
Feb 2018
Primary outcomePrimary: Diastolic Blood Pressure Change — -8.56; -11.26 mmHg — p=0.0001
◆ Published Evidence
Established
60citations · ~4 / year
Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan (50/100 mg): a 12-week, phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension.
Summary
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) 60 mg~120 mg in patients with mild to moderate essential hypertension.
Linked Publications (2)
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Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan (50/100 mg): a 12-week, phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension.
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Fimasartan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diastolic Blood Pressure Change |
-5.73; -8.22; -8.01; -11.01 | 0.0001 sig |
| SECONDARY Diastolic Blood Pressure Change |
-5.73; -8.22; -8.01; -11.01 | 0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Placebo visit and Baseline are 90~109mmHg inclusive and the difference between sitting diastolic blood pressures measured at Placebo visit and Baseline(Day0) 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 89mmHg or more than 110mmHg 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 12weeks, 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(include carrier)
- 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 participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons
Data sourced from ClinicalTrials.gov (NCT00922480) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.