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])
Uncontrolled hypertension | Systolic Pressure | Diabetes Mellitus | Renal Insufficiency | Diastolic blood pressure | Antihypertensive therapy Stable | RAAS Inhibitor Single | Angiotensin-Converting Enzyme Inhibitor | Angiotensin II receptor antagonist | DIRECT RENIN INHIBITOR | Creatinine measurement, serum | Gender | Creatinine clearance measurement
Item
3. patients with uncontrolled hypertension as defined sbp > 140 mmhg and sbp > 130 mmhg in patients with diabetes or renal impairment or dbp > 90 mmhg and dbp >80 mmhg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single raas blocking agent (angiotensin converting enzym inhibition, aii receptor blocker and direct renin inhibitor) at entering the trial. renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
C0585941 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
C0086907 (UMLS CUI [7,1])
C1999216 (UMLS CUI [7,2])
C0205171 (UMLS CUI [7,3])
C0003015 (UMLS CUI [8])
C0521942 (UMLS CUI [9])
C1950687 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
C0079399 (UMLS CUI [12])
C0373595 (UMLS CUI [13])
Premenopausal state | Female Sterilization Absent | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Transdermal patch as birth control method | Contraceptives, Oral | Contraceptive implant | Injectable contraception | Sexual Abstinence | Partner had vasectomy
Item
1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
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])
C3831118 (UMLS CUI [6,1])
C0032976 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
C2135981 (UMLS CUI [7])
C0009905 (UMLS CUI [8])
C1657106 (UMLS CUI [9])
C1262153 (UMLS CUI [10])
C0036899 (UMLS CUI [11])
C0420842 (UMLS CUI [12])
Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma
Item
2. 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])
Sitting systolic blood pressure mean | Systolic Pressure | Diabetes Mellitus | Renal Insufficiency | Diastolic blood pressure | Creatinine measurement, serum | Gender | Creatinine clearance measurement
Item
3. mean in-clinic seated cuff systolic bp >180 mmhg and sbp >160 mmhg in patients with diabetes or renal impairment or diastolic bp >110 mmhg and dbp >100 mmhg in patients with diabetes or renal impairment. renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0079399 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
Renal dysfunction | Creatinine measurement, serum | Creatinine clearance measurement | Renal Insufficiency Severe
Item
4. renal dysfunction as defined by the following laboratory parameters: serum creatinine >3.0 mg/dl (or >265 ¿mol/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
5. 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
6. clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 meq/l).
boolean
C0020621 (UMLS CUI [1])
C0020461 (UMLS CUI [2])
C0202194 (UMLS CUI [3])
Hyponatremia | Hypovolemia
Item
7. uncorrected sodium or volume depletion.
boolean
C0020625 (UMLS CUI [1])
C0546884 (UMLS CUI [2])
Primary aldosteronism
Item
8. primary aldosteronism.
boolean
C1384514 (UMLS CUI [1])
Hereditary fructose intolerance syndrome
Item
9. hereditary fructose intolerance.
boolean
C0016751 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
10. congestive heart failure new york heart association functional class congestive heart failure iii-iv (refer to appendix 10.1).
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Tachycardia, Ventricular | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia
Item
11. 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])
Bile Duct Diseases Obstructive | Cholestasis | Hepatic Insufficiency | SERUM TOTAL BILIRUBIN ELEVATED | Transaminases increased
Item
12. biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x transaminases values). (refer to appendix 10.3)
boolean
C0005395 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0008370 (UMLS CUI [2])
C1306571 (UMLS CUI [3])
C0595866 (UMLS CUI [4])
C0438717 (UMLS CUI [5])
Symptoms Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
13. 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
14. history of drug or alcohol dependency within six months prior to signing the informed consent form.
boolean
C0038580 (UMLS CUI [1])
Investigational New Drugs
Item
15. any investigational drug therapy within one month of signing the informed consent.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Component Investigational New Drug | Hypersensitivity Telmisartan | Amlodipine allergy
Item
16. known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).
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])
C0570921 (UMLS CUI [3])
Medication Nonadherence | Protocol Compliance Unable
Item
17. history of non-compliance or inability to comply with prescribed medications or protocol procedures.
boolean
C0746935 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Medical condition Preventing Completion of clinical trial | Medical condition Preventing Administration Investigational New Drugs
Item
18. 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])