Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01135212
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT01135212
Study Brief:
Protocol Section:
NCT01135212