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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT06174766
Eligibility Criteria:
Inclusion Criteria:
1. Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions
* sitSBP\<180 mmHg and sitDBP\<110mg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
* 140mmHG≤sitSBP\<180mmHg and 60mmHg≤sitDBP\<110mmHg
2. Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions
* 24h-ABPM: 130mmHg≤ SBP \<170mmHg
* clinic BP: 140 mmHg ≤ sitSBP \< 180 mmHg and 60 mmHg ≤ sitDBP \< 110 mmHg
Exclusion Criteria:
1. Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
2. Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
3. Orthostatic hypotension with symptoms within 3 months prior to visit 1
4. Secondary hypertension patient or suspected to be
5. Uncontrolled type II diabetes mellitus (HbA1c \> 9%) or type I diabetes mellitus
6. Severe heart disease or severe neurovascular disease
7. Moderate or malignant retinopathy
8. Severe renal diseases (eGFR\<30mL/min/1.73m2)
9. Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)
10. Hypokalemia or Hyperkalemia (K\<3.5mmol/L or K ≥ 5.5mmol/L)
11. Hyponatremia or Hypernatremia (Na\<135mmol/L or Na ≥ 155mmol/L)
12. History of malignancy tumor
13. History of alcohol or drug abuse
14. Positive to pregnancy test, nursing mother, intention on pregnancy
15. Considered by investigator as not appropriate to participate in the clinical study with other reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06174766
Study Brief:
Protocol Section:
NCT06174766