Sitting diastolic blood pressure mean
Item
patients with mean sitting diastolic blood pressure ≥ 100 mmhg and < 110 mmhg
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Inclusion criteria Extension
Item
inclusion criteria for the extension:
boolean
C1512693 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
mssbp ≥ 140 mm hg and/or msdbp ≥ 90 mm hg at visit 5 of the core study
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Exclusion Criteria Clinical Trial Main
Item
exclusion criteria for core study:
boolean
C0680251 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Diastolic blood pressure mean | Systolic Pressure mean
Item
patients with mean diastolic blood pressure ≥ 110 mmhg or mean systolic blood pressure ≥ 180 mmhg
boolean
C0428883 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Cerebrovascular accident | Hypertensive Encephalopathy | Myocardial Infarction
Item
patients with prior stroke, hypertensive encephalopathy or heart attack
boolean
C0038454 (UMLS CUI [1])
C0151620 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent
Item
patients with type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Glucose Poorly controlled
Item
patients with type 2 diabetes mellitus with poor glucose control
boolean
C0011860 (UMLS CUI [1])
C0017725 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Exclusion Criteria Extension
Item
exclusion criteria for the extension:
boolean
C0680251 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Clinical Trial Discontinuation Early | Protocol Compliance failed
Item
premature discontinuation in the core study or failure to comply with the core study protocol
boolean
C0008976 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar | Medical contraindication Diuretics | Medical contraindication Suspected Diuretics | Medical contraindication Amlodipine | Medical contraindication Suspected Amlodipine | Hypotension, severe | Shock
Item
history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to diuretics as described in the smpc (particularly amlodipine 5 mg), e.g. severe hypotension, shock -
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C1301624 (UMLS CUI [3,1])
C0012798 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0012798 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C0051696 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0051696 (UMLS CUI [6,3])
C2678378 (UMLS CUI [7])
C0036974 (UMLS CUI [8])
Shock, Cardiogenic | Obstruction Impairing Blood flow Left ventricle | Aortic Stenosis
Item
including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e.g. significant aortic stenosis)
boolean
C0036980 (UMLS CUI [1])
C0028778 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0232338 (UMLS CUI [2,3])
C0225897 (UMLS CUI [2,4])
C0003507 (UMLS CUI [3])
Clinical Trial Extension | Medical reasons Study Subject Participation Status Excluded
Item
any patient that the investigator decides should not participate in the extension study for medical reasons
boolean
C0008976 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
C3841427 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
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])