ID

29912

Beschreibung

26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00624052

Link

https://clinicaltrials.gov/show/NCT00624052

Stichworte

Versionen (2)
  1. 26.04.18 26.04.18 -
  2. 26.04.18 26.04.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. April 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypertension NCT00624052

Englisch

Eligibility Hypertension NCT00624052

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of essential hypertension
Beschreibung

Essential Hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0085580
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
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).
Beschreibung

Condition Worsening Possible | Cause Telmisartan Dosage | Cause Amlodipine Dosage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332271
UMLS CUI [1,3]
C0332149
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0248719
UMLS CUI [2,3]
C0178602
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0051696
UMLS CUI [3,3]
C0178602
discontinuation from the preceding trial.
Beschreibung

Clinical Trial preceding Discontinuation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C1444662
known or suspected secondary hypertension.
Beschreibung

Secondary hypertension | Secondary hypertension Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
mean seated systolic blood pressure (sbp) >= 180 mmhg and/or mean seated diastolic blood pressure (dbp) >= 120 mmhg at any visit.
Beschreibung

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
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.
Beschreibung

Hepatic impairment | Renal Insufficiency Severe | Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Solitary | Renal Artery Stenosis post Kidney Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0856760
UMLS CUI [4,1]
C0035067
UMLS CUI [4,2]
C0022646
UMLS CUI [4,3]
C0205171
UMLS CUI [5,1]
C0035067
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0022671
clinically relevant hyperkalaemia.
Beschreibung

Hyperkalemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0020461
uncorrected volume or sodium depletion.
Beschreibung

Sodium Volume uncorrected | Sodium depletion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037473
UMLS CUI [1,2]
C0449468
UMLS CUI [1,3]
C4072785
UMLS CUI [2]
C0020625
primary aldosteronism.
Beschreibung

Primary aldosteronism

Datentyp

boolean

Alias
UMLS CUI [1]
C1384514
hereditary fructose or lactose intolerance.
Beschreibung

Hereditary fructose intolerance | Lactose Intolerance Hereditary

Datentyp

boolean

Alias
UMLS CUI [1]
C0016751
UMLS CUI [2,1]
C0022951
UMLS CUI [2,2]
C0439660
symptomatic congestive heart failure.
Beschreibung

Symptomatic congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0742758
patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ace) inhibitors or angiotensin receptor blockers (arbs).
Beschreibung

Symptoms Characteristic Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1521970
UMLS CUI [1,3]
C0002994
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
any new drug or alcohol dependency since signing consent of the preceding trial.
Beschreibung

Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
Beschreibung

Study Subject Participation Status | Therapy, Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
Beschreibung

Hypertrophic Cardiomyopathy | Aortic Valve Stenosis | Mitral Valve Stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0003507
UMLS CUI [3]
C0026269
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0248719
UMLS CUI [3]
C2585204
UMLS CUI [4]
C0570921
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C2945601
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C1321605
UMLS CUI [6,3]
C0013230
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0521942
UMLS CUI [2]
C2945601
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C2732579
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C0248719
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C0051696
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Ähnliche Modelle

Eligibility Hypertension NCT00624052

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension
Item
diagnosis of essential hypertension
boolean
C0085580 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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