Age
Item
males or females 18 - 70 years
boolean
C0001779 (UMLS CUI [1])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Measurement Visit Quantity | Difference mean Diastolic blood pressure
Item
mean seated systolic blood pressure (sbp) ≥ 140 mmhg and < 180 mmhg and mean seated diastolic blood pressure (dbp) > 90 and < 109 mmhg at two consecutive qualifying visits (visits 3/3.5 and visit 4). the mean difference in dbp between the two consecutive qualifying visits must be ≤ 10 mmhg.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0242485 (UMLS CUI [3,1])
C1512346 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1705242 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
C0428883 (UMLS CUI [4,3])
Childbearing Potential Sexually active Contraceptive methods Quantity | Postmenopausal state
Item
women of child-bearing potential (wocbp) must use two reliable forms of contraception if sexually active. alternatively, female subjects must be postmenopausal (for at least 1 year).
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0232970 (UMLS CUI [2])
Disease Serious | Other Coding | Investigational New Drugs Evaluation Limited | Cardiovascular Diseases | Coronary Artery Disease | Kidney Diseases | Absence Kidney Quantity | Lung diseases | Liver diseases | Gastrointestinal Diseases | Malabsorption | Endocrine System Diseases | Metabolic Diseases | Hematological Disease | Nervous system disorder | Mental disorders
Item
subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of ps433540, including cardiovascular (includes subjects who are known to have coronary artery disease), renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic, neurologic and psychiatric diseases.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0007222 (UMLS CUI [4])
C1956346 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0332197 (UMLS CUI [7,1])
C0022646 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
C0024115 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0017178 (UMLS CUI [10])
C0024523 (UMLS CUI [11])
C0014130 (UMLS CUI [12])
C0025517 (UMLS CUI [13])
C0018939 (UMLS CUI [14])
C0027765 (UMLS CUI [15])
C0004936 (UMLS CUI [16])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
history of malignancy other than adequately treated basal cell or squamous cell skin cancer.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Myocardial Infarction | Heart failure New York Heart Association Classification
Item
subjects with a history of myocardial infarction or new york heart association (nyha) class ii-iv heart failure.
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
subjects with a history of cerebrovascular accident or transient ischemic attack.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Conduction disorder of the heart | Second degree atrioventricular block | Complete atrioventricular block | Left Bundle-Branch Block | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter | Accessory cardiac pathway | Cardiac Arrhythmia Requirement Pharmaceutical Preparations
Item
subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular block (av block), left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
boolean
C0264886 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0023211 (UMLS CUI [4])
C0037052 (UMLS CUI [5])
C0004238 (UMLS CUI [6])
C0004239 (UMLS CUI [7])
C1963785 (UMLS CUI [8])
C0003811 (UMLS CUI [9,1])
C1514873 (UMLS CUI [9,2])
C0013227 (UMLS CUI [9,3])
Valvular disease Hemodynamic Significant
Item
subjects with hemodynamically significant valvular disease.
boolean
C3258293 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents | Oral medication | Insulin | Exenatide
Item
subjects with history of type 1 diabetes mellitus and subjects with a history of type 2 diabetes mellitus using antihyperglycemic medication (oral medication, insulin, or exenatide) are excluded.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0020616 (UMLS CUI [3])
C0175795 (UMLS CUI [4])
C0021641 (UMLS CUI [5])
C0167117 (UMLS CUI [6])