Outpatients | Age
Item
outpatients 18-75 years of age.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender
Item
male or female patients are eligible.
boolean
C0079399 (UMLS CUI [1])
Hypertensive disease
Item
patients with a diagnosis of hypertension:
boolean
C0020538 (UMLS CUI [1])
Patients Newly Diagnosed | Antihypertensive therapy Absent | Sitting systolic blood pressure mean
Item
newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a mean sitting systolic blood pressure (mssbp) > 150 mmhg and < 180 mmhg at visit 1.
boolean
C0030705 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0585941 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Antihypertensive therapy | Sitting systolic blood pressure mean
Item
patients treated with antihypertensive monotherapy must have a mssbp ≥ 140 mmhg and <180 mmhg at visit 1.
boolean
C0585941 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Amlodipine | Sitting systolic blood pressure mean
Item
patients taking amlodipine monotherapy mssbp > 140 mmhg and < 180 mmhg at visit 1.
boolean
C0051696 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Patients All | Sitting systolic blood pressure mean
Item
all patients must have a mssbp ≥ 140 mmhg and < 180 mmhg at visit 3, the end of the amlodipine run-in period.
boolean
C0030705 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Metabolic Syndrome
Item
metabolic syndrome.
boolean
C0524620 (UMLS CUI [1])
Study Subject Participation Status eligible | Informed Consent
Item
patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written inform consent form).
boolean
C2348568 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
severe hypertension (office cuff msdbp ≥ 115 mmhg and/or mssbp ≥ 180 mmhg).
boolean
C4013784 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Secondary hypertension
Item
history or evidence of a secondary form of hypertension.
boolean
C0155616 (UMLS CUI [1])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
history of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (tia), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (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])
Serum sodium measurement
Item
serum sodium < 135 mmol/l at visit 1 if confirmed on repeat sample.
boolean
C0523891 (UMLS CUI [1])
Serum potassium measurement
Item
serum potassium < 3.5 mmol/l or ≥ 5.3 mmol/l at visit 1, if confirmed on repeat sample.
boolean
C0302353 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | ORAL HYPOGLYCEMIC TREATMENT Changed | Drug dosage altered | Change of medication
Item
type 2 diabetes if oral hypoglycaemic therapy changed (dose change or medication change) in previous 3 months.
boolean
C0011860 (UMLS CUI [1])
C0747045 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0420247 (UMLS CUI [3])
C0580105 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria applied to the study.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])