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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00853957
Eligibility Criteria:
Inclusion Criteria:
* Men or women of African American background; self identified
* Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and \< 200 mmHg at Visit 5 (randomization
Exclusion Criteria:
* Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
* Patients on 4 or more antihypertensive medications.
* Patients with uncontrolled hypertension (MSSBP \>180 mmHg) taking more than 1 antihypertensive medication at Visit 1
* Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Evidence of a secondary form of hypertension, including but not limited to any of the following:
* coarctation of the aorta
* hyperaldosteronism
* unilateral or bilateral renal artery stenosis
* Cushing's disease
* polycystic kidney disease
* pheochromocytoma
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of angioedema due to usage of an ARB or ACE inhibitor.
* History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months
Other protocol defined inclusion/exclusion criteria applied
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00853957
Study Brief:
Protocol Section:
NCT00853957