Outpatients
Item
1. male or female outpatients
boolean
C0029921 (UMLS CUI [1])
Mild hypertension Untreated | Moderate hypertensive disease Untreated | Antihypertensive therapy Mild hypertension | Antihypertensive therapy Hypertensive disease Moderate
Item
2. patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy
boolean
C3276943 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0585941 (UMLS CUI [3,1])
C3276943 (UMLS CUI [3,2])
C0585941 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
C0205081 (UMLS CUI [4,3])
Antihypertensive therapy | Sitting systolic blood pressure mean | Randomization Visit | Visit Preceding
Item
3. treated patients (using antihypertensive treatments within 4 weeks prior to visit 1) must have an mssbp ≥150 mmhg and <180 mmhg at the randomization visit and mssbp ≥140 mmhg <180 mmhg at the preceding visit.
boolean
C0585941 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0034656 (UMLS CUI [3,1])
C0008952 (UMLS CUI [3,2])
C0008952 (UMLS CUI [4,1])
C0332152 (UMLS CUI [4,2])
Patients Untreated | Sitting systolic blood pressure mean | Randomization Visit | Visit Preceding
Item
4. untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to visit 1) must have an mssbp ≥150 mmhg and <180 mmhg at both the randomization visit and the preceding visit.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0034656 (UMLS CUI [3,1])
C0008952 (UMLS CUI [3,2])
C0008952 (UMLS CUI [4,1])
C0332152 (UMLS CUI [4,2])
Difference Sitting systolic blood pressure mean | Randomization Visit | Visit Preceding
Item
5. patients must have an absolute difference of ≤15 mmhg in mssbp between the randomization visit and the preceding visit.
boolean
C1705242 (UMLS CUI [1,1])
C1319893 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0034656 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
C0008952 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
Able to communicate | Protocol Compliance | Medication Compliance Percentage
Item
6. ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the treatment run-in period.
boolean
C2364293 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C3489773 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
1. severe hypertension (msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg)
boolean
C4013784 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
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 | Primary hyperaldosteronism | 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
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])
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])
Pregnancy | Breast Feeding
Item
6. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent | Eligibility Criteria Study Protocol
Item
7. women of child-bearing potential not using highly effective methods of contraception other protocol defined inclusion/exclusion criteria may apply
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1516637 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])