Informed Consent
Item
patients must give written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female ages 18 or older and less than 86 years
boolean
C0001779 (UMLS CUI [1])
Essential diastolic hypertension
Item
diagnosed as having essential diastolic hypertension, as follows:
boolean
C3694763 (UMLS CUI [1])
Single-Blind Method | Sitting diastolic blood pressure mean
Item
visit 2/single-blind run-in entry, all participants must have a msdbp ≥ 95 mmhg and < 100 mmhg
boolean
C0037181 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Double-Blind Method | Sitting diastolic blood pressure mean
Item
at visit 3/core double-blind treatment period entry, all patients must have a msdbp >=90 mmhg and <110 mmhg
boolean
C0013072 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Hypertension, severe
Item
severe hypertension
boolean
C4013784 (UMLS CUI [1])
Secondary hypertension | Aortic coarctation | Hyperaldosteronism | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Cushing's disease | Pheochromocytoma | Polycystic Kidney Diseases
Item
evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, cushing's disease, pheochromocytoma or polycystic kidney disease )
boolean
C0155616 (UMLS CUI [1])
C0003492 (UMLS CUI [2])
C0020428 (UMLS CUI [3])
C0856759 (UMLS CUI [4])
C0856760 (UMLS CUI [5])
C0221406 (UMLS CUI [6])
C0031511 (UMLS CUI [7])
C0022680 (UMLS CUI [8])
Malignant Hypertension
Item
malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Antihypertensive Agents
Item
administration of any agent indicated for the treatment of hypertension after visit 1
boolean
C0003364 (UMLS CUI [1])
Retinal Disease Moderate | Retinal Disease Malignant
Item
known moderate or malignant retinopathy.
boolean
C0035309 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
Medical contraindication Angiotensin II receptor antagonist | Medical contraindication Suspected Angiotensin II receptor antagonist | Allergy to angiotensin II receptor antagonist | Medical contraindication Calcium Channel Blockers | Medical contraindication Suspected Calcium Channel Blockers | Calcium-channel blocker allergy | Medical contraindication Pharmaceutical Preparations Chemical Structure Similar | Medical contraindication Suspected Pharmaceutical Preparations Chemical Structure Similar | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin ii receptor blockers (arbs), calcium channel blockers (ccbs), or to drugs with similar chemical structures
boolean
C1301624 (UMLS CUI [1,1])
C0521942 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0521942 (UMLS CUI [2,3])
C2585204 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0006684 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0006684 (UMLS CUI [5,3])
C0570913 (UMLS CUI [6])
C1301624 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C0220807 (UMLS CUI [7,3])
C2348205 (UMLS CUI [7,4])
C1301624 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C0013227 (UMLS CUI [8,3])
C0220807 (UMLS CUI [8,4])
C2348205 (UMLS CUI [8,5])
C0020517 (UMLS CUI [9,1])
C0013227 (UMLS CUI [9,2])
C0220807 (UMLS CUI [9,3])
C2348205 (UMLS CUI [9,4])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Revascularization Type All | Angina Pectoris Type Any | Angina, Unstable
Item
history of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0581603 (UMLS CUI [5,1])
C0332307 (UMLS CUI [5,2])
C0444868 (UMLS CUI [5,3])
C0002962 (UMLS CUI [6,1])
C0332307 (UMLS CUI [6,2])
C1552551 (UMLS CUI [6,3])
C0002965 (UMLS CUI [7])
Heart failure New York Heart Association Classification
Item
history of heart failure grade ii-iv according to new york heart association (nyha) classification
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Second degree atrioventricular block Independent of Artificial cardiac pacemaker | Complete atrioventricular block Independent of Artificial cardiac pacemaker | Second degree atrioventricular block Independent of Cardiac Arrhythmia Life Threatening | Complete atrioventricular block Independent of Cardiac Arrhythmia Life Threatening | Second degree atrioventricular block Independent of ARRHYTHMIA SYMPTOMATIC | Complete atrioventricular block Independent of ARRHYTHMIA SYMPTOMATIC
Item
second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia
boolean
C0264906 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0030163 (UMLS CUI [1,3])
C0151517 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0030163 (UMLS CUI [2,3])
C0264906 (UMLS CUI [3,1])
C0332291 (UMLS CUI [3,2])
C0003811 (UMLS CUI [3,3])
C2826244 (UMLS CUI [3,4])
C0151517 (UMLS CUI [4,1])
C0332291 (UMLS CUI [4,2])
C0003811 (UMLS CUI [4,3])
C2826244 (UMLS CUI [4,4])
C0264906 (UMLS CUI [5,1])
C0332291 (UMLS CUI [5,2])
C0741212 (UMLS CUI [5,3])
C0151517 (UMLS CUI [6,1])
C0332291 (UMLS CUI [6,2])
C0741212 (UMLS CUI [6,3])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])