Essential Hypertension Established Untreated | Essential Hypertension Established Treated Uncontrolled
Item
established essential hypertension, untreated or treated but uncontrolled with treatment:
boolean
C0085580 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0085580 (UMLS CUI [2,1])
C0443211 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0205318 (UMLS CUI [2,4])
Systolic Pressure Patients Untreated
Item
office sbp ≥ 160 mmhg for untreated patients
boolean
C0871470 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
Systolic Pressure Patients Treated | Antihypertensive Agents
Item
office sbp ≥ 140 mmhg for patients already treated with an antihypertensive drug.
boolean
C0871470 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2])
Antihypertensive therapy Pharmaceutical Preparation Single | Antihypertensive therapy Combined Modality Therapy
Item
previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:
boolean
C0585941 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C0585941 (UMLS CUI [2,1])
C0009429 (UMLS CUI [2,2])
Angiotensin-Converting Enzyme Inhibitors | Calcium Channel Blockers
Item
ace inhibitor / calcium channel blocker
boolean
C0003015 (UMLS CUI [1])
C0006684 (UMLS CUI [2])
Adrenergic beta-Antagonists | Calcium Channel Blockers
Item
beta blocker / calcium channel blocker
boolean
C0001645 (UMLS CUI [1])
C0006684 (UMLS CUI [2])
Adrenergic beta-Antagonists | Diuretics Low dose
Item
beta blocker / low dose diuretic
boolean
C0001645 (UMLS CUI [1])
C0012798 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
Angiotensin-Converting Enzyme Inhibitors | Diuretics Low dose
Item
ace inhibitor / low dose diuretic
boolean
C0003015 (UMLS CUI [1])
C0012798 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
Systolic Pressure | Diastolic blood pressure
Item
sbp ≥ 180 mmhg and/or dbp ≥ 110 mmhg evaluated at doctor's office at visit 1
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Secondary hypertension Causes | Secondary hypertension Causes Suspected
Item
known or suspected causes of secondary hypertension
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0155616 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Bilateral renal artery stenosis | Renal Artery Stenosis Single kidney | Kidney Transplantation | Single functional kidney
Item
patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
boolean
C0856760 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C1849176 (UMLS CUI [2,2])
C0022671 (UMLS CUI [3])
C1504368 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Kidney Diseases | Metabolic Diseases | Gastrointestinal Diseases | Malignant Neoplasms | Disease Study Subject Participation Status Unfavorable
Item
significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the investigator to make participation in the study not in the best interest of the subject
boolean
C0007222 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C3640815 (UMLS CUI [8,3])
Diuretic allergy | Allergy to sulfonamides | Angioedema Associated with Angiotensin II receptor antagonist | Cough Associated with Angiotensin II receptor antagonist | Angioedema Associated with Pharmaceutical Preparations | Cough Associated with Pharmaceutical Preparations
Item
known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin ii receptor antagonist or any combination of the drugs used
boolean
C0571893 (UMLS CUI [1])
C0038757 (UMLS CUI [2])
C0002994 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0521942 (UMLS CUI [3,3])
C0010200 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0521942 (UMLS CUI [4,3])
C0002994 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C0010200 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
Medical contraindication Investigational New Drugs
Item
known contraindications to any of the study drugs
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Antihypertensive therapy
Item
concomitant use of any other antihypertensive treatment
boolean
C0585941 (UMLS CUI [1])
Investigational New Drugs
Item
use of any of the investigational products for this study within the 3 months prior to the study
boolean
C0013230 (UMLS CUI [1])
Home Blood Pressure Monitoring Unable | Obesity | circumference of arm | Cardiac Arrhythmia
Item
inability to obtain a valid hbpm recording i.e., obesity, arm circumference > 32 cm or arrhythmia
boolean
C1449681 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0028754 (UMLS CUI [2])
C2075184 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
Investigational New Drugs
Item
administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Lacking | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Pregnancy Tests Unable
Item
women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])