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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07352969
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent.
2. Males or females aged 18 to 75 years.
3. Diagnosis of primary hypertension without anti-HTN medication or with one anti-HTN medication
4. Mean sitting SBP ≥140 mmHg and \< 170 mmHg measured by OBPM.
5. Participants able to understand and comply with study procedures.
Exclusion Criteria:
1. Known history of secondary hypertension.
2. Orthostatic hypotension.
3. Laboratory parameter assessments outside of range at screening：
* Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 2× Upper Limit of Normal (ULN)
* Total Bilirubin \> 1.5× ULN
* International Normalized Ratio (INR) \> 2.0
* Serum Potassium \> 5 mg/L
* Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL/min/1.73m²
* QTcF \> 480 ms
4. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
5. Current or history of intolerance to ACEi and/or ARBs.
6. Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening. Any history of congestive heart failure.
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07352969
Study Brief:
Protocol Section:
NCT07352969