Informed Consent
Item
1. ability to provide written informed consent in accordance with good clinical practice and local legislation;
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age 18 years or older;
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease Grade | Systolic Pressure | Diastolic blood pressure
Item
3. patients with grade 2 or grade 3 hypertension as defined sbp>=160 mmhg and dbp>=100 mmhg at randomization
boolean
C0020538 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Ability Antihypertensive therapy Discontinue | Absence Patient Risk
Item
4. ability to stop any current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
boolean
C0085732 (UMLS CUI [1,1])
C0585941 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
Premenopausal state | Female Sterilization Absent | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Intrauterine Devices | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Patch estrogen | Hormonal contraception
Item
1. pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are not practicing acceptable methods of birth control, or do not plan to continue practicing an acceptable method throughout the trial. the only acceptable methods of birth control are: intra-uterine device (iud), oral contraceptives, implantable or injectable contraceptives, estrogen patch hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
boolean
C0232969 (UMLS CUI [1])
C0015787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C1656586 (UMLS CUI [9])
C3843379 (UMLS CUI [10])
C2985296 (UMLS CUI [11])
Night shift worker
Item
2. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
boolean
C0555008 (UMLS CUI [1])
Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma
Item
3. known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0035067 (UMLS CUI [3])
C0031511 (UMLS CUI [4])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
4. mean in-clinic seated cuff sbp>= 200 mmhg and/or dbp >=120 mmhg
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Renal dysfunction | Creatinine measurement, serum | Creatinine clearance measurement | Renal Insufficiency Severe
Item
5. renal dysfunction as defined by the following laboratory parameters: serum creatinine >3.0 mg/dl (or >265 umol/l) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C1565489 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Bilateral renal artery stenosis | Renal Artery Stenosis Kidney solitary | Status post Kidney Transplantation | Patients Kidney solitary
Item
6. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
boolean
C0856760 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0022671 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C0022646 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
Hypokalemia | Hyperkalemia | Potassium measurement
Item
7. clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/l or >5.5 mmol/l, may be rechecked for suspected error in result)
boolean
C0020621 (UMLS CUI [1])
C0020461 (UMLS CUI [2])
C0202194 (UMLS CUI [3])
Hyponatremia uncorrected | Hypovolemia uncorrected
Item
8. uncorrected sodium or volume depletion
boolean
C0020625 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0546884 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
Conn Syndrome
Item
9. primary aldosteronism.
boolean
C1384514 (UMLS CUI [1])
Hereditary fructose intolerance
Item
10. hereditary fructose intolerance
boolean
C0016751 (UMLS CUI [1])
Obstruction of biliary tree | Cholestasis | Hepatic Insufficiency
Item
11. biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
boolean
C0400979 (UMLS CUI [1])
C0008370 (UMLS CUI [2])
C1306571 (UMLS CUI [3])
Congestive heart failure New York Heart Association Classification
Item
12. congestive heart failure new york heart association functional class congestive heart failure iii-iv (refer to appendix 10.3)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Medical contraindication Placebo Run-in Period | Cerebrovascular accident | Myocardial Infarction | Cardiac Surgery procedures | Percutaneous Transluminal Coronary Angioplasty | Angina, Unstable | Coronary Artery Bypass Surgery
Item
13. contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run in period)
boolean
C1301624 (UMLS CUI [1,1])
C0032042 (UMLS CUI [1,2])
C3274438 (UMLS CUI [1,3])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0018821 (UMLS CUI [4])
C2936173 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0010055 (UMLS CUI [7])
Tachycardia, Ventricular | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia
Item
14. clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
boolean
C0042514 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
C0004239 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
Hypertrophic Cardiomyopathy | Coronary Artery Disease Obstructive Severe | Aortic Valve Stenosis Hemodynamic Relevant | Mitral Valve Stenosis Hemodynamic Relevant
Item
15. hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
boolean
C0007194 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0549186 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0003507 (UMLS CUI [3,1])
C0019010 (UMLS CUI [3,2])
C2347946 (UMLS CUI [3,3])
C0026269 (UMLS CUI [4,1])
C0019010 (UMLS CUI [4,2])
C2347946 (UMLS CUI [4,3])
Unstable diabetes mellitus | Diabetic - poor control | Hemoglobin A1c measurement
Item
16. patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an glycosylated hemoglobin >=10%
boolean
C0342302 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Symptoms Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
17. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin-ii receptor antagonists
boolean
C1457887 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
Substance Dependence
Item
18. history of drug or alcohol dependency within 6 months prior to signing the informed consent form
boolean
C0038580 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Blood Pressure | Exception Study Protocol Medication
Item
19. concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Pharmacotherapy Investigational
Item
20. any investigational drug therapy within 1 month of signing the informed consent
boolean
C0013216 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Hypersensitivity Component Investigational New Drugs | Hypersensitivity Telmisartan | Hydrochlorothiazide allergy | Hypersensitivity Placebo
Item
21. known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0248719 (UMLS CUI [2,2])
C0571898 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0032042 (UMLS CUI [4,2])
Compliance behavior Lacking | Medication Compliance Unable | Protocol Compliance Unable
Item
22. history of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in)
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C3489773 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Other medical condition Preventing Completion of clinical trial | Other medical condition Preventing Administration Investigational New Drugs
Item
23. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])