Informed Consent
Item
1. written informed consent in accordance with good clinical practices and local legislations
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age between ≥25 and ≤ 65 years
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease Stage | Systolic Pressure | Diastolic blood pressure
Item
3. patients with hypertension stage 1 as defined by systolic blood pressure (sbp) ≥140 but <159 mmhg and diastolic blood pressure (dbp) ≥90 but < 99 mmhg at randomization
boolean
C0020538 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Ability Discontinue Antihypertensive therapy | Risk Unacceptable Absent
Item
4. ability to stop any current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
boolean
C0085732 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0585941 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2,1])
C1883420 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Body mass index
Item
5. bmi ≥25 and ≤35.
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Medical History | Oral Glucose Tolerance Test | Glucose measurement, fasting
Item
6. patients with type 2 diabetes mellitus can participate and will be stratified before randomization. diagnosis can be established by clinical history, 75-g oral glucose tolerance test (ada criteria), or fasting glucose > 126 mg/dl.
boolean
C0011860 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0029161 (UMLS CUI [3])
C0202045 (UMLS CUI [4])
Premenopausal | Female Sterilization Absent | Breast Feeding | Pregnancy | Gender Contraceptive methods Absent
Item
1. pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who are not surgically sterile, nursing, are pregnant or without any anticonceptive methods.
boolean
C0279752 (UMLS CUI [1])
C0015787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Hypersensitivity Investigational New Drugs
Item
2. known hypersensitivity to the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Gastrointestinal Surgical Procedure Changing Drug absorption | Gastrointestinal Surgical Procedure Changing Substance distribution | Gastrointestinal Surgical Procedure Changing Drug metabolism
Item
3. gastrointestinal surgery which might alter absorption, distribution, or drug metabolism.
boolean
C0524722 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0524722 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1378698 (UMLS CUI [2,3])
C0524722 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
Angioedema Relationship Angiotensin-Converting Enzyme Inhibitors | Angioedema Relationship Angiotensin II receptor antagonist
Item
4. history of angioedema related to ace inhibitors or angiotensin ii receptor blockers.
boolean
C0002994 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0003015 (UMLS CUI [1,3])
C0002994 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0521942 (UMLS CUI [2,3])
Night shift worker
Item
5. 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
6. known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0035067 (UMLS CUI [3])
C0031511 (UMLS CUI [4])
Systolic Pressure | Diastolic blood pressure
Item
7. sbp≥160 mmhg and/or dbp ≥100 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Renal dysfunction | Creatinine measurement, serum | Creatinine clearance measurement | Clinical Markers Renal Insufficiency Severe
Item
8. renal dysfunction as defined by: serum creatinine >3.0 mg/dl (or >265 umol/l) and/or creatinine clearance <30 ml/min and/or other clinical markers of severe renal impairment.
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0008963 (UMLS CUI [4,1])
C1565489 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Functioning Solitary | Status post Kidney Transplantation | Patients Kidney Single
Item
9. bilateral renal arterial stenosis, renal artery stenosis in a solitary functional kidney, post-renal transplant patients or patients with one kidney
boolean
C0856760 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
C0542341 (UMLS CUI [2,3])
C0205171 (UMLS CUI [2,4])
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
Item
10. 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])
Hyponatremia uncorrected | Hypovolemia uncorrected
Item
11. 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])
Primary aldosteronism
Item
12. primary aldosteronism.
boolean
C1384514 (UMLS CUI [1])
Hereditary fructose intolerance
Item
13. hereditary fructose intolerance
boolean
C0016751 (UMLS CUI [1])
Biliary obstruction | Cholestasis | Hepatic Insufficiency
Item
14. 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
15. congestive heart failure class iii-iv according to criteria fron the new york heart association.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Tachycardia, Ventricular | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia
Item
16. 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 | Aortic Valve Stenosis Hemodynamic Relevant | Mitral Valve Stenosis Hemodynamic Relevant
Item
17. 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])
C0003507 (UMLS CUI [4,1])
C0019010 (UMLS CUI [4,2])
C2347946 (UMLS CUI [4,3])
C0026269 (UMLS CUI [5,1])
C0019010 (UMLS CUI [5,2])
C2347946 (UMLS CUI [5,3])
Unstable diabetes mellitus | Diabetic - poor control | Hemoglobin A1c measurement | Glucose measurement, fasting
Item
18. patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an glycosylated hemoglobin a1c >=10% or fasting glucose greater than 400 mg/dl.
boolean
C0342302 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C0202045 (UMLS CUI [4])
Symptoms Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
19. 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
20. 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 Pharmaceutical Preparations allowed
Item
21. 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])
C0013227 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Investigational New Drugs
Item
22. any investigational drug therapy within 1 month of signing the informed consent
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Component Investigational New Drugs | Hypersensitivity Telmisartan | Hydrochlorothiazide allergy | Hypersensitivity Placebo
Item
23. 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])
C1696465 (UMLS CUI [4,2])
Compliance behavior Lacking | Protocol Compliance Unable
Item
24. 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])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Other medical condition Preventing Completion of clinical trial | Other medical condition Preventing Administration Investigational New Drugs
Item
25. 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])