Age
Item
1. male and female patients ≥ 60 years of age.
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension Untreated | Essential Hypertension | Antihypertensive therapy
Item
2. patients with essential hypertension, untreated or currently taking antihypertensive therapy.
boolean
C0085580 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0085580 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
Patients untreated | Sitting systolic blood pressure mean | Hypertensive disease Newly Diagnosed | Antihypertensive Agents Absent
Item
3. untreated patients must have an office mssbp ≥150 mmhg and <180 mmhg at visit 101 and visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to visit 1.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0020538 (UMLS CUI [3,1])
C1518321 (UMLS CUI [3,2])
C0003364 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Patients Treated | Sitting systolic blood pressure mean | Visit Number | Antihypertensive therapy
Item
4. treated patients must have an office mssbp ≥140 mmhg and <180 mmhg at visit 102 (or visit 103) and mssbp ≥150 mmhg and <180 mmhg at visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to visit 1.
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1512346 (UMLS CUI [3,1])
C0237753 (UMLS CUI [3,2])
C0585941 (UMLS CUI [4])
Pulse Pressure Result | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
5. all patients must have pulse pressure >60 mmhg at visit 201. pulse pressure is defined as mssbp- msdbp.
boolean
C0949236 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Difference Sitting systolic blood pressure mean | Visit Number | Visit preceding
Item
6. patients must have a difference in mssbp within +/-15 mmhg between visit 201 (randomization) and the visit immediately prior to visit 201.
boolean
C1705242 (UMLS CUI [1,1])
C1319893 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C1512346 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C1512346 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
Malignant Hypertension | Severe Hypertension Grade WHO classification | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
1. malignant or severe hypertension (grade 3 of who classification; msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg)
boolean
C0020540 (UMLS CUI [1])
C4013784 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C4267671 (UMLS CUI [2,3])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C1319893 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
Angioedema Drug-induced | Angioedema
Item
2. history of angioedema, drug-related or otherwise.
boolean
C0002994 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C0002994 (UMLS CUI [2])
Secondary hypertension | Parenchymal renal hypertension | Hypertension, Renovascular | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Aortic coarctation | Conn Syndrome | Cushing's disease | Pheochromocytoma | Polycystic Kidney Diseases | Hypertensive disease Drug-induced
Item
3. history or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
boolean
C0155616 (UMLS CUI [1])
C0264649 (UMLS CUI [2])
C0020545 (UMLS CUI [3])
C0856759 (UMLS CUI [4])
C0856760 (UMLS CUI [5])
C0003492 (UMLS CUI [6])
C1384514 (UMLS CUI [7])
C0221406 (UMLS CUI [8])
C0031511 (UMLS CUI [9])
C0022680 (UMLS CUI [10])
C0020538 (UMLS CUI [11,1])
C0458082 (UMLS CUI [11,2])
Transient Ischemic Attack | Cerebrovascular accident
Item
4. transient ischemic cerebral attack (tia) during the 12 months prior to visit 1 or any history of stroke.
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
5. history of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (pci) during the 12 months prior to visit 1.
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
Atrial Fibrillation | Atrial Flutter | Atrial Fibrillation by ECG | Atrial Flutter by ECG
Item
6. history of atrial fibrillation or atrial flutter during the 3 months prior to visit 1, or active atrial fibrillation or atrial flutter on the ecg at screening.
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
C0344434 (UMLS CUI [3])
C0344423 (UMLS CUI [4])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])