Outpatients | Age
Item
outpatients ≥18 years of age.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hypertensive disease Stage | Sitting systolic blood pressure mean
Item
patients with a diagnosis of stage ii hypertension, defined as mean sitting systolic blood pressure (mssbp) ≥ 160 mmhg and < 180 mmhg at visit 2.
boolean
C0020538 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Hypertension, severe | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
severe hypertension defined as mssbp ≥ 180 mmhg and/or mean sitting diastolic blood pressure (msdbp) ≥ 110 mmhg.
boolean
C4013784 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Secondary hypertension
Item
secondary form of hypertension.
boolean
C0155616 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
current diagnosis of heart failure (new york heart association [nyha] class ii-iv).
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina Pectoris Requirement Pharmacotherapy | Exception Nitrates Oral | Exception Nitrates Topical
Item
current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
boolean
C0002962 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0028125 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0028125 (UMLS CUI [3,2])
C1522168 (UMLS CUI [3,3])
Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent
Item
second or third degree heart block without a pacemaker.
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC | Atrial Fibrillation | Atrial Flutter
Item
concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to visit 1.
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0741212 (UMLS CUI [2])
C0004238 (UMLS CUI [3])
C0004239 (UMLS CUI [4])
Heart valve disease
Item
clinically significant valvular heart disease.
boolean
C0018824 (UMLS CUI [1])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
previous history of hypertensive encephalopathy or stroke, transcient ischemic attack (tia), heart attack, coronary bypass surgery or any pci.
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C1532338 (UMLS CUI [6])
Hypertensive Retinopathy Grade
Item
known keith-wagener grade iii or iv hypertensive retinopathy.
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Antihypertensive therapy Combined | Antihypertensive Agents Class Quantity
Item
in the month prior to visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications.
boolean
C0585941 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Antihypertensive Agents Combined | Antihypertensive Agents Class Quantity
Item
patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
boolean
C0003364 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Antihypertensive Agents Unable to discontinue | Cardiovascular Agents Unable to discontinue
Item
inability to discontinue prior antihypertensive or other cv medications as required by the protocol.
boolean
C0003364 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0007220 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
patients with type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
patients with type 2 diabetes mellitus not well controlled .
boolean
C0011860 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Serum potassium increased
Item
elevated serum potassium (over 5.3 meq/l (mmol/l).
boolean
C0553704 (UMLS CUI [1])
Operative Surgical Procedures Changing Absorption Investigational New Drugs | Operative Surgical Procedures Changing Distribution Investigational New Drugs | Operative Surgical Procedures Changing Metabolism Investigational New Drugs | Operative Surgical Procedures Changing Elimination Investigational New Drugs | Medical condition Changing Absorption Investigational New Drugs | Medical condition Changing Distribution Investigational New Drugs | Medical condition Changing Metabolism Investigational New Drugs | Medical condition Changing Elimination Investigational New Drugs
Item
any surgical or medical condition or the use of any medication which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
boolean
C0543467 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1378698 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0025519 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0543467 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C0013230 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C1378698 (UMLS CUI [6,3])
C0013230 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C0392747 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C0013230 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0392747 (UMLS CUI [8,2])
C0683141 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])