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Phase 2 N=92 Randomized Quadruple-blind Treatment

A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension

Essential Hypertension

Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Mean Change of Diastolic Blood Pressure — -10.15; -7.19; -6.70 mmHg — p=<0.05

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Fimasartan 60 mg group (Drug); Fimasartan 120 mg group (Drug); Reference (Valsartan 80 mg) group (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boryung Pharmaceutical Co., Ltd
Primary completion
Aug 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change of Diastolic Blood Pressure
-10.15; -7.19; -6.70 <0.05 sig

Summary

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension.

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 1.5mg/dl), 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
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00922441). 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.

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