Age
Item
at least 55 years of age.
boolean
C0001779 (UMLS CUI [1])
hypertension untreated | Hypertensive disease Treated
Item
previously untreated or treated hypertension.
boolean
C0745134 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Age | Cardiovascular Diseases Quantity Evidence of | Target Organ Damage | Target Organ Damage Related body system Different
Item
for patients >= 60 years, evidence of at least one cv disease or target organ damage, or for patients 55-59 years evidence of at least two cv diseases or target organ damage from two different organ systems as defined in the protocol.
boolean
C0001779 (UMLS CUI [1])
C0007222 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
C0743496 (UMLS CUI [3])
C0743496 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0460002 (UMLS CUI [4,3])
C1705242 (UMLS CUI [4,4])
Hypersensitivity Investigational New Drugs
Item
allergy to any of the drugs administered in this trial.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Angina Pectoris | Angina Pectoris Event Requirement Nitroglycerin
Item
current angina pectoris (ie, no anginal event requiring ntg within 1 month prior to visit 1).
boolean
C0002962 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0441471 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0017887 (UMLS CUI [2,4])
Secondary hypertension
Item
secondary hypertension.
boolean
C0155616 (UMLS CUI [1])
Refractory hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Treatment | Sympatholytics | Diuretics | Vasodilator Agents
Item
refractory hypertension defined as sbp >= 180 mmhg and/or dbp >= 110 mmhg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators.
boolean
C0860493 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0205269 (UMLS CUI [4])
C0039051 (UMLS CUI [5])
C0012798 (UMLS CUI [6])
C0042402 (UMLS CUI [7])
Heart failure Symptomatic | New York Heart Association Classification | Cardiac ejection fraction
Item
history of symptomatic heart failure (nyha classes ii-iv) or ejection fraction < 40%.
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
C0232174 (UMLS CUI [3])
Myocardial Infarction | Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angina, Unstable
Item
myocardial infarction, coronary revascularization (cabg or pci), unstable angina within one month of visit 1.
boolean
C0027051 (UMLS CUI [1])
C0877341 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
Cerebrovascular accident | Transient Ischemic Attack
Item
stroke or transient ischemic event (tia) within 3 months of visit 1.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
disease; valve, valvular (obstructive) Significant | Cardiovascular Disease Significant | Valvular disease Resulting in Operative Surgical Procedures
Item
significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study.
boolean
C1384985 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C3258293 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
Liver disease Evidence of | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
evidence of hepatic disease (ast or alt values >= 2 x upper limit of normal).
boolean
C0023895 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum
Item
impaired renal function (serum creatinine >= 2.5 mg/dl (221 µmol/l)).
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Serum potassium measurement | Potassium supplement
Item
baseline serum potassium of > 5.2 meq/l not on potassium supplements.
boolean
C0302353 (UMLS CUI [1])
C0304475 (UMLS CUI [2])
Malignant Neoplasms | leukemia | Lymphoma | Basal cell carcinoma
Item
history of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years.
boolean
C0006826 (UMLS CUI [1])
C0023418 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
C0007117 (UMLS CUI [4])
Autoimmune Diseases Clinical Significance | Lupus Erythematosus, Systemic
Item
history of clinically significant auto immune disorders such as systemic lupus erythematosus.
boolean
C0004364 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0024141 (UMLS CUI [2])
Illness Significant Resulting in Cessation of life Probably | Organ Transplantation Major | Life Expectancy
Item
significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy <5 years).
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332294 (UMLS CUI [1,3])
C0011065 (UMLS CUI [1,4])
C0750492 (UMLS CUI [1,5])
C0029216 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Cardiovascular Disease Significant | Aortic Aneurysm Requirement Probably Operative Surgical Procedures
Item
significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study.
boolean
C0007222 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0003486 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0750492 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria applied to the study.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])