Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Stable
Item
patients diagnosed with type ii diabetes that are on stable treatment with hypoglycemic agents
boolean
C0011860 (UMLS CUI [1])
C0020616 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Run-in Period Placebo Single-Blind
Item
patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 140 mmhg but <200 mmhg and a msdbp less than or equal to 114 mmhg following a 3 to 4-week single-blind placebo run-in period
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C3274438 (UMLS CUI [3,1])
C1696465 (UMLS CUI [3,2])
C0037181 (UMLS CUI [3,3])
Sitting systolic blood pressure mean Timepoint Difference
Item
the difference in mssbp between visits 3 and 4 or between visits 4 and 4x must be less than or equal to 10 mmhg
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
C1705242 (UMLS CUI [1,4])
Systolic Pressure mean Daytime | Diastolic blood pressure mean Daytime | Blood Pressure Monitoring, Ambulatory | Run-in Period Placebo
Item
patients with a mean daytime (8am - 4pm) sbp > 130 mmhg and less than or equal to 199 mmhg and a mean daytime dbp less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (abpm) following placebo run-in period
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
C0428883 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0332169 (UMLS CUI [2,3])
C0242876 (UMLS CUI [3])
C3274438 (UMLS CUI [4,1])
C1696465 (UMLS CUI [4,2])
Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy | Tubal Ligation | Childbearing Potential Contraceptive methods
Item
if female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study
boolean
C0079399 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0520483 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
history of stroke or transient ischemic attack (tia) within the last one year
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Myocardial Infarction | Coronary revascularisation Transluminal Percutaneous | Coronary Artery Bypass Surgery | Angina, Unstable
Item
history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
boolean
C0027051 (UMLS CUI [1])
C0877341 (UMLS CUI [2,1])
C0522520 (UMLS CUI [2,2])
C0522523 (UMLS CUI [2,3])
C0010055 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
Proteinuria
Item
presence of overt proteinuria at screening
boolean
C0033687 (UMLS CUI [1])
Hypertension, severe | Diastolic blood pressure | Systolic Pressure
Item
severe hypertension (dbp greater than or equal to 115 mmhg or sbp greater than or equal to 200 mmhg)
boolean
C4013784 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
Secondary hypertension Etiology Any | Kidney Diseases | Pheochromocytoma | Cushing Syndrome
Item
patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or cushing's syndrome
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2])
C0031511 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin
Item
type i or type ii diabetes requiring insulin
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Bradycardia At rest Symptomatic | Congestive heart failure | Heart valve disease Hemodynamic Significant
Item
evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease
boolean
C0428977 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0018802 (UMLS CUI [2])
C0018824 (UMLS CUI [3,1])
C0019010 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
Heart Block | First degree sinoatrial block | Wolff-Parkinson-White Syndrome | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter
Item
presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, atrial fibrillation, or atrial flutter
boolean
C0018794 (UMLS CUI [1])
C3854673 (UMLS CUI [2])
C0043202 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0004239 (UMLS CUI [6])