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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT01788358
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of \>/= 160 mmHg and \< 200 mmHg, as measured by a calibrated electronic BP measuring device. For other subjects who are treated with antihypertensive medication before, they should have MSSBP \>/= 160 mmHg and \<200 mmHg after wash out.
* Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active
Exclusion Criteria:
* Mean seated systolic blood pressure \>/= 200 mmHg and/or mean seated diastolic blood pressure \>/= 120 mm/Hg
* Mean seated diastolic blood pressure \< 60 mm/Hg
* Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0
* Any history of hypertensive emergency
* Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
* Cerebrovascular ischemic event (stroke, transient ischemic attack \[TIA\])within the previous 12 months
* History of intracerebral hemorrhage or subarachnoid hemorrhage
* History of hypertensive retinopathy - known Keith-Wagener Grade III or IV
* Any history of heart failure, New York Heart Association (NYHA) classification III or IV
* Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
* Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of greater than 9% on visit 0.
* Hyperkalemia: potassium above the upper limit of normal in the laboratory range
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01788358
Study Brief:
Protocol Section:
NCT01788358