Outpatients | Age
Item
male or female outpatients >= 18 years and < 86 years
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Essential diastolic hypertension
Item
patients with essential diastolic hypertension
boolean
C3694763 (UMLS CUI [1])
Visit Number | Sitting diastolic blood pressure mean | Antihypertensive Agents
Item
at visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmhg and < 10 mmhg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmhg
boolean
C1549755 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3])
Visit Number | Sitting diastolic blood pressure mean
Item
at visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmhg and < 100 mmhg
boolean
C1549755 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Visit Number | Sitting diastolic blood pressure mean
Item
at visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmhg and < 110 mmhg
boolean
C1549755 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Hypertension, severe
Item
severe hypertension >= 180/110 mmhg
boolean
C4013784 (UMLS CUI [1])
Medical contraindication Valsartan | Medical contraindication Suspected Valsartan | Medical contraindication Amlodipine | Medical contraindication Suspected Amlodipine | Hypersensitivity Valsartan | Amlodipine allergy | Hypersensitivity Pharmaceutical Preparations Similar
Item
known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
boolean
C1301624 (UMLS CUI [1,1])
C0216784 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0216784 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0051696 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0051696 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0216784 (UMLS CUI [5,2])
C0570921 (UMLS CUI [6])
C0020517 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C2348205 (UMLS CUI [7,3])
Antihypertensive Agents Unable to discontinue
Item
inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to visit 2
boolean
C0003364 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Revascularization
Item
history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0581603 (UMLS CUI [5])
Malignant Hypertension
Item
malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
all patients with type i diabetes and those patients with type 2 diabetes who are not well controlled based on the investigator's clinical judgment
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart failure
Item
history of heart failure
boolean
C0018801 (UMLS CUI [1])
Angina Pectoris
Item
angina pectoris
boolean
C0002962 (UMLS CUI [1])
Second degree atrioventricular block | Complete atrioventricular block
Item
second or third degree heart block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC
Item
life threatening or symptomatic arrhythmias
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0741212 (UMLS CUI [2])
Heart valve disease
Item
clinically significant valvular heart disease
boolean
C0018824 (UMLS CUI [1])
Secondary hypertension
Item
evidence of a secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
Retinal Disease Malignant | Retinal Disease Malignant Moderate
Item
known or moderate malignant retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
Liver disease
Item
evidence of hepatic disease
boolean
C0023895 (UMLS CUI [1])
Renal Insufficiency
Item
evidence of renal impairment
boolean
C1565489 (UMLS CUI [1])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria may apply.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])