Hypertension
Item
have a documented medical history of hypertension.
boolean
C0020538 (UMLS CUI [1])
Diastolic blood pressure
Item
have cuff seated diastolic blood pressure values greater than or equal to 95 and less than or equal to 104 mm at study entry
boolean
C0428883 (UMLS CUI [1])
Negative serum pregnancy test, contraception
Item
have a negative serum pregnancy test at the time of enrollment and agree to use two medically reliable methods of contraception until study completion, if female is of child-bearing potential, between menarche and 1 year post menopause and not surgically sterilized.
boolean
C0430060 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Patient Compliance
Item
are able to comply with study procedures and visits
boolean
C1321605 (UMLS CUI [1])
Resistant hypertension or systolic hypertension
Item
have resistant hypertension or systolic hypertension.
boolean
C0745130 (UMLS CUI [1])
C0221155 (UMLS CUI [2])
Obesity
Item
are obese, defined as having body mass index (bmi) greater than or equal to 35.
boolean
C1305855 (UMLS CUI [1])
Pregnancy or breast feeding
Item
are females who are pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Renal insufficiency or thyroid, renal or hepatic disease
Item
have a history of severe renal insufficiency or significant thyroid, renal or hepatic disease.
boolean
C1565489 (UMLS CUI [1])
C0040128 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
HbA1C
Item
have a glycosylated hemoglobin a1c (hba1c) greater than or equal to 10% during the screening period.
boolean
C0202054 (UMLS CUI [1])
Anemia
Item
have significant anemia.
boolean
C0002871 (UMLS CUI [1])
significant or unstable cardiac history
Item
have a significant or unstable cardiac history such as history of heart attack, unstable angina, or stroke within 6 months of study entry, history of angina that was treated with long- or short-acting nitrates within 90 days of study entry, history of coronary artery bypass graft surgery or cardiac angioplasty within 90 days of study entry, history of abnormal heart rhythms such as sick sinus syndrome or 2nd- or 3rd-degree av block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, a history of recurrent ventricular tachycardia, or symptomatic bradycardia, a history of sudden cardiac arrest.
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0002962 (UMLS CUI [5,1])
C0017887 (UMLS CUI [5,2])
C0010055 (UMLS CUI [6])
C0190211 (UMLS CUI [7])
C0003811 (UMLS CUI [8])
C0037052 (UMLS CUI [9])
C0004245 (UMLS CUI [10])
C0694539 (UMLS CUI [11])
C0080203 (UMLS CUI [12,1])
C0018792 (UMLS CUI [12,2])
C1737264 (UMLS CUI [13])
C0428977 (UMLS CUI [14])
C1720824 (UMLS CUI [15])
symptomatic heart failure or significant disease of the heart valves
Item
have symptomatic heart failure requiring treatment, or significant disease of the heart valves.
boolean
C0018801 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
Severe asthma, bronchospasm, or copd
Item
have been treated for severe asthma, bronchospasm, or copd within 3 months of study entry.
boolean
C0004096 (UMLS CUI [1])
C0006266 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
Peripheral vascular disease
Item
have severe peripheral vascular disease.
boolean
C0085096 (UMLS CUI [1])
Sleep apnea
Item
have a documented diagnosis of sleep apnea.
boolean
C0037315 (UMLS CUI [1])