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:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT00937651
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
1. Women of childbearing potential who have not received the hysterectomy or men who are not willing to use birth control measures.
2. Patients whose sitting DBP is \< 95mmHg or ≥ 115mmHg. Patients with severe hypertension whose SBP is ≥200mmHg
3. Patients with secondary hypertension
4. Patients with severe renal disease, gastrointestinal disorder, hematologic disorder, liver disease, etc. that can affect the absorption, distribution, metabolism and excretion of drugs
5. Patients with symptoms of orthostatic hypotension
6. Patients with severe insulin dependent diabetes or uncontrolled diabetes
7. 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
8. Patients with consumption disease, autoimmune disease, or connective tissue disease
9. Patients with the history of type B hepatitis or type C hepatitis
10. Patients with HIV infection or hepatitis
11. Patients with clinically significant abnormal laboratory test findings
12. Patients on any drug treatment that might affect the blood pressure
13. Patients with allergy or contraindication to angiotensin II-receptor antagonists
14. Patients with current or suspected alcohol addiction or history of drug abuse
15. Patients whose mean weight lies out of the range of -15% \~ +35%, based on the Modified Metropolitan Life Insurance table
16. Patients who are not eligible as subjects of the study, as determined by the principal investigator or a sub-investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00937651
Study Brief:
Protocol Section:
NCT00937651