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Completed

Phase 3
Age: 19Years - 75Years
All Genders
ID01135212

A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension Phase IIIb

Led by Boryung Pharmaceutical Co., Ltd · Updated on 2012-08-24

290

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

B

Boryung Pharmaceutical Co., Ltd

Lead Sponsor

K

Kyungpook National University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.

CONDITIONS

Brief Title

The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

Who Can Participate

Age: 19Years - 75Years
All Genders

Eligibility Criteria

Inclusion Criteria:

  1. Subjects who agreed to participate in this study and submitted the written informed consent
  2. Subjects aged 19 to 75 years
  3. Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
  4. Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.

Exclusion Criteria:

  1. Severe hypertension patients; more 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)
  2. Patients with secondary hypertension
  3. Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
  4. Patients with hypotension who has sign and symptom
  5. Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
  6. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin)
  7. Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
  8. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
  9. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
  10. Patients with severe cerebrovascular disease
  11. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
  12. Patients with known severe or malignancy retinopathy
  13. Patients with hepatitis B or C or HIV positive reaction
  14. Patients who have a story or evidence of alcohol or drug abuse within 2years
  15. Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
  16. Patients with history of allergic reaction to any angiotensin II antagonist
  17. Patients with any chronic inflammation disease needed to chronic inflammation therapy
  18. Childbearing and breast-feeding women
  19. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
  20. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
  21. Subject who are judged unsuitable to participate in this study by investigator

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