Essential Hypertension
Item
diagnosis of essential hypertension
boolean
C0085580 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Condition Worsening Possible | Cause Telmisartan Dosage | Cause Amlodipine Dosage
Item
development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (t40/a10) or telmisartan 80mg/amlodipine 10mg (t80/a10).
boolean
C0348080 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0248719 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0051696 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
Clinical Trial preceding Discontinuation
Item
discontinuation from the preceding trial.
boolean
C0008976 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
Secondary hypertension | Secondary hypertension Suspected
Item
known or suspected secondary hypertension.
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
mean seated systolic blood pressure (sbp) >= 180 mmhg and/or mean seated diastolic blood pressure (dbp) >= 120 mmhg at any visit.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Hepatic impairment | Renal Insufficiency Severe | Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Solitary | Renal Artery Stenosis post Kidney Transplantation
Item
any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0856760 (UMLS CUI [3])
C0035067 (UMLS CUI [4,1])
C0022646 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
C0035067 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0022671 (UMLS CUI [5,3])
Hyperkalemia
Item
clinically relevant hyperkalaemia.
boolean
C0020461 (UMLS CUI [1])
Sodium Volume uncorrected | Sodium depletion
Item
uncorrected volume or sodium depletion.
boolean
C0037473 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
C0020625 (UMLS CUI [2])
Primary aldosteronism
Item
primary aldosteronism.
boolean
C1384514 (UMLS CUI [1])
Hereditary fructose intolerance | Lactose Intolerance Hereditary
Item
hereditary fructose or lactose intolerance.
boolean
C0016751 (UMLS CUI [1])
C0022951 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
Symptomatic congestive heart failure
Item
symptomatic congestive heart failure.
boolean
C0742758 (UMLS CUI [1])
Symptoms Characteristic Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ace) inhibitors or angiotensin receptor blockers (arbs).
boolean
C1457887 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C0002994 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
Substance Dependence
Item
any new drug or alcohol dependency since signing consent of the preceding trial.
boolean
C0038580 (UMLS CUI [1])
Study Subject Participation Status | Therapy, Investigational
Item
concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Hypertrophic Cardiomyopathy | Aortic Valve Stenosis | Mitral Valve Stenosis
Item
hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
boolean
C0007194 (UMLS CUI [1])
C0003507 (UMLS CUI [2])
C0026269 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs Component | Hypersensitivity Telmisartan | Allergy to angiotensin II receptor antagonist | Amlodipine allergy | Hypersensitivity Dihydropyridine Calcium Channel Blocker | Absence Compliance behavior Investigational New Drugs
Item
known allergic hypersensitivity to any component of the formulations under investigation. [includes known hypersensitivity to telmisartan or other arbs or amlodipine or other dihydropyridine calcium channel blockers (ccbs).] non-compliance with study medication (defined as <80% or >120%) during the preceding trial.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0248719 (UMLS CUI [2,2])
C2585204 (UMLS CUI [3])
C0570921 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C2945601 (UMLS CUI [5,2])
C0332197 (UMLS CUI [6,1])
C1321605 (UMLS CUI [6,2])
C0013230 (UMLS CUI [6,3])
Angiotensin II receptor antagonist | Dihydropyridine Calcium Channel Blocker | Exception Investigational New Drugs | Medical condition Preventing Completion of clinical trial | Medical condition Excludes Telmisartan | Medical condition Excludes Amlodipine
Item
administration of arbs or dihydropyridine ccbs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
boolean
C0521942 (UMLS CUI [1])
C2945601 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C3843040 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0248719 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0051696 (UMLS CUI [6,3])