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:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT06121518
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who are 19 years old or older.
2. Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria:
* Didn't take antihypertensive drug
* 140 mmHg ≤ MSSBP(mean sitting SBP) \< 180 mmHg
* Taking antihypertensive drug
* 130 mmHg ≤ MSSBP(mean sitting SBP) \< 180 mmHg
3. Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.
Exclusion Criteria:
1. Subjects with a history of secondary hypertension or suspected secondary hypertension
2. Subjects with symptomatic orthostatic hypotension
3. Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c \> 9.0%)
4. Subjects with Severe heart failure(NYHA Class 3,4) etc.,
5. Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening
6. Subjects with a history of disability to investigational product ADME at the time of screening
7. Subjects with abnormalities in laboratory test results at the time of screening
8. Subjects with hypersensitivity or history of investigational product and similar drugs
9. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
10. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
11. Subjects who received other investigational product within 4 weeks of screening visit
12. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last investigational product
13. Subjects who are unable to participate in this clinical trial at the discretion of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06121518
Study Brief:
Protocol Section:
NCT06121518