Age
Item
male or female aged 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough | Antihypertensive Agents Absent
Item
mean trough seated systolic blood pressure (sesbp) of ≥ 160/100 mmhg (sesbp of ≥ 160 mmhg and seated diastolic blood pressure (sedbp) ≥ 100 mmhg) at screening if not currently on antihypertensive medication (e.g. newly diagnosed subjects)
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,3])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0444506 (UMLS CUI [2,3])
C0003364 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Study Subject Therapeutic procedure | Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough
Item
for subjects on monotherapy: mean trough sesbp of ≥ 150/95 mmhg (sesbp of ≥ 150 mmhg and sedbp ≥ 95 mmhg) at screening
boolean
C0681850 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0444506 (UMLS CUI [2,3])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0444506 (UMLS CUI [3,3])
Antihypertensive Agents Combination | Hydrochlorothiazide | Amlodipine | olmesartan | Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough
Item
for subjects on any combination of antihypertensive medications that includes either hydrochlorothiazide or amlodipine or olmesartan for a duration of at least four weeks: mean trough sesbp of ≥ 140/90 mmhg (sesbp of ≥ 140 mmhg and sedbp ≥ 90 mmhg) at screening
boolean
C0003364 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0020261 (UMLS CUI [2])
C0051696 (UMLS CUI [3])
C1098320 (UMLS CUI [4])
C1319893 (UMLS CUI [5,1])
C0444504 (UMLS CUI [5,2])
C0444506 (UMLS CUI [5,3])
C1319894 (UMLS CUI [6,1])
C0444504 (UMLS CUI [6,2])
C0444506 (UMLS CUI [6,3])
Antihypertensive Agents Combination | Hydrochlorothiazide Absent | Amlodipine Absent | Olmesartan Absent | Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough
Item
for subjects on any other combination of antihypertensive medications that includes neither hydrochlorothiazide, amlodipine nor olmesartan: mean trough sesbp ≥ 160 mmhg, mean trough sedbp ≥ 100mmhg, at the end of the taper-off period
boolean
C0003364 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0020261 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0051696 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1098320 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1319893 (UMLS CUI [5,1])
C0444504 (UMLS CUI [5,2])
C0444506 (UMLS CUI [5,3])
C1319894 (UMLS CUI [6,1])
C0444504 (UMLS CUI [6,2])
C0444506 (UMLS CUI [6,3])
Informed Consent
Item
subject freely signs the informed consent form (icf) after the nature of the study and the disclosure of his/her data has been explained.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Postmenopausal state Absent | Female Sterilization Absent | Hysterectomy Absent | Contraceptives, Oral | Intrauterine Devices | Contraceptives, Oral, Hormonal | Depot contraceptive | Contraceptive patch | Injectable contraception | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | CONTRACEPTIVE SUPPLY, SPERMICIDE (E.G., FOAM, GEL)
Item
female subjects of childbearing potential must be using adequate contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study [visit 1]). females taking oral contraceptives should have been on therapy for at least three months. adequate contraceptives include hormonal intra-uterine devices, hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. if a female becomes pregnant during the study, she has to be withdrawn immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0020699 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0009905 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009907 (UMLS CUI [7])
C0419531 (UMLS CUI [8])
C2985284 (UMLS CUI [9])
C1262153 (UMLS CUI [10])
C0004764 (UMLS CUI [11,1])
C0205173 (UMLS CUI [11,2])
C0221829 (UMLS CUI [12])
C0042241 (UMLS CUI [13])
C1144908 (UMLS CUI [14])
Pregnancy | Breast Feeding
Item
female subjects of childbearing potential who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Serious Limiting Evaluation | Cerebrovascular Disorders | Cardiovascular Diseases | Kidney Diseases | Respiration Disorders | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Metabolic Diseases | Hematological Disease | Malignant disease | Nervous system disorder | Mental disorders | Immunocompromised patient | Neutropenia
Item
subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of the investigational products, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological, and psychiatric diseases. the same applies for immunocompromised and/or neutropenic subjects.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0007820 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0442867 (UMLS CUI [11])
C0027765 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C0085393 (UMLS CUI [14])
C0027947 (UMLS CUI [15])
Myocardial Infarction | Angina, Unstable | Percutaneous Coronary Intervention | Heart failure | Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack
Item
subjects having a history of the following within the last six months: myocardial infarction (mi), unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischaemic attack.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C0151620 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
Laboratory test result abnormal
Item
subjects with clinically significant abnormal laboratory values at screening, including subjects with one or more of the following:
boolean
C0438215 (UMLS CUI [1])
Aspartate aminotransferase increased
Item
aspartate aminotransferase (ast) > 3 times upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alanine aminotransferase (alt) > 3 times uln
boolean
C0151905 (UMLS CUI [1])
Gamma-glutamyl transferase raised
Item
gamma-glutamyltransferase (ggt) > 3 times uln
boolean
C0151662 (UMLS CUI [1])
Potassium increased | Exception Due to Blood specimen Hemolytic
Item
potassium above uln (unless high value is due to haemolytic blood sample)
boolean
C0856882 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0178913 (UMLS CUI [2,3])
C0312853 (UMLS CUI [2,4])
Secondary hypertension caused by Kidney Disease | Secondary hypertension caused by Pheochromocytoma | Secondary hypertension caused by Cushing Syndrome
Item
subjects with secondary hypertension of any aetiology such as renal disease, phaeochromocytoma, or cushing's syndrome.
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0022658 (UMLS CUI [1,3])
C0155616 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0031511 (UMLS CUI [2,3])
C0155616 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0010481 (UMLS CUI [3,3])
Medical contraindication Olmesartan | Medical contraindication Amlodipine | Medical contraindication Hydrochlorothiazide | Medical contraindication Olmesartan Excipient | Medical contraindication Amlodipine Excipient | Medical contraindication Hydrochlorothiazide Excipient
Item
subjects with contraindication to olmesartan, amlodipine, hydrochlorothiazide, or any of the excipients.
boolean
C1301624 (UMLS CUI [1,1])
C1098320 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0051696 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0020261 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C1098320 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C0051696 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C1301624 (UMLS CUI [6,1])
C0020261 (UMLS CUI [6,2])
C0015237 (UMLS CUI [6,3])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Bradycardia | RESTING HEART RATE beats per minute | Radial pulse rate mean | Electrocardiography
Item
subjects with a mean sesbp > 200 mmhg or mean sedbp > 115 mmhg or bradycardia (heart rate < 50 beats/min at rest documented by mean radial pulse rate [pr] or electrocardiogram [ecg]) at screening (visit 1) or immediately before taking period i study medication (visit 2).
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0428977 (UMLS CUI [3])
C1821417 (UMLS CUI [4,1])
C0439385 (UMLS CUI [4,2])
C0518831 (UMLS CUI [5,1])
C0444504 (UMLS CUI [5,2])
C1623258 (UMLS CUI [6])