ID

29989

Descrição

Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00867490

Link

https://clinicaltrials.gov/show/NCT00867490

Palavras-chave

Versões (1)
  1. 02/05/2018 02/05/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

2 de maio de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT00867490

Inglês

Eligibility Hypertension NCT00867490

1 Formulários  
Criteria
Descrição

Criteria

patients with mean sitting diastolic blood pressure ≥ 100 mmhg and < 110 mmhg
Descrição

Sitting diastolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
inclusion criteria for the extension:
Descrição

Inclusion criteria Extension

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0231448
mssbp ≥ 140 mm hg and/or msdbp ≥ 90 mm hg at visit 5 of the core study
Descrição

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
exclusion criteria for core study:
Descrição

Exclusion Criteria Clinical Trial Main

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1542147
patients with mean diastolic blood pressure ≥ 110 mmhg or mean systolic blood pressure ≥ 180 mmhg
Descrição

Diastolic blood pressure mean | Systolic Pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0444504
patients with prior stroke, hypertensive encephalopathy or heart attack
Descrição

Cerebrovascular accident | Hypertensive Encephalopathy | Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0151620
UMLS CUI [3]
C0027051
patients with type 1 diabetes mellitus
Descrição

Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
patients with type 2 diabetes mellitus with poor glucose control
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Glucose Poorly controlled

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0017725
UMLS CUI [2,2]
C3853134
exclusion criteria for the extension:
Descrição

Exclusion Criteria Extension

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0231448
premature discontinuation in the core study or failure to comply with the core study protocol
Descrição

Clinical Trial Discontinuation Early | Protocol Compliance failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1279919
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0231175
history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to diuretics as described in the smpc (particularly amlodipine 5 mg), e.g. severe hypotension, shock -
Descrição

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar | Medical contraindication Diuretics | Medical contraindication Suspected Diuretics | Medical contraindication Amlodipine | Medical contraindication Suspected Amlodipine | Hypotension, severe | Shock

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0220807
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0012798
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0012798
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0051696
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C0051696
UMLS CUI [7]
C2678378
UMLS CUI [8]
C0036974
including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e.g. significant aortic stenosis)
Descrição

Shock, Cardiogenic | Obstruction Impairing Blood flow Left ventricle | Aortic Stenosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2,1]
C0028778
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0232338
UMLS CUI [2,4]
C0225897
UMLS CUI [3]
C0003507
any patient that the investigator decides should not participate in the extension study for medical reasons
Descrição

Clinical Trial Extension | Medical reasons Study Subject Participation Status Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0231448
UMLS CUI [2,1]
C3841427
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
other protocol-defined inclusion/exclusion criteria applied to the study.
Descrição

Eligibility Criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hypertension NCT00867490

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Sitting diastolic blood pressure mean
Item
patients with mean sitting diastolic blood pressure ≥ 100 mmhg and < 110 mmhg
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Inclusion criteria Extension
Item
inclusion criteria for the extension:
boolean
C1512693 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
mssbp ≥ 140 mm hg and/or msdbp ≥ 90 mm hg at visit 5 of the core study
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Exclusion Criteria Clinical Trial Main
Item
exclusion criteria for core study:
boolean
C0680251 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Diastolic blood pressure mean | Systolic Pressure mean
Item
patients with mean diastolic blood pressure ≥ 110 mmhg or mean systolic blood pressure ≥ 180 mmhg
boolean
C0428883 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Cerebrovascular accident | Hypertensive Encephalopathy | Myocardial Infarction
Item
patients with prior stroke, hypertensive encephalopathy or heart attack
boolean
C0038454 (UMLS CUI [1])
C0151620 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent
Item
patients with type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Glucose Poorly controlled
Item
patients with type 2 diabetes mellitus with poor glucose control
boolean
C0011860 (UMLS CUI [1])
C0017725 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Exclusion Criteria Extension
Item
exclusion criteria for the extension:
boolean
C0680251 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Clinical Trial Discontinuation Early | Protocol Compliance failed
Item
premature discontinuation in the core study or failure to comply with the core study protocol
boolean
C0008976 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar | Medical contraindication Diuretics | Medical contraindication Suspected Diuretics | Medical contraindication Amlodipine | Medical contraindication Suspected Amlodipine | Hypotension, severe | Shock
Item
history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to diuretics as described in the smpc (particularly amlodipine 5 mg), e.g. severe hypotension, shock -
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C1301624 (UMLS CUI [3,1])
C0012798 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0012798 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C0051696 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0051696 (UMLS CUI [6,3])
C2678378 (UMLS CUI [7])
C0036974 (UMLS CUI [8])
Shock, Cardiogenic | Obstruction Impairing Blood flow Left ventricle | Aortic Stenosis
Item
including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e.g. significant aortic stenosis)
boolean
C0036980 (UMLS CUI [1])
C0028778 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0232338 (UMLS CUI [2,3])
C0225897 (UMLS CUI [2,4])
C0003507 (UMLS CUI [3])
Clinical Trial Extension | Medical reasons Study Subject Participation Status Excluded
Item
any patient that the investigator decides should not participate in the extension study for medical reasons
boolean
C0008976 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
C3841427 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria applied to the study.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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