ID

17611

Descrição

Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00095394

Link

https://clinicaltrials.gov/show/NCT00095394

Palavras-chave

Versões (1)
  1. 26/09/2016 26/09/2016 -
Transferido a

26 de setembro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT00095394

Inglês

Eligibility Hypertension NCT00095394

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ages 18 and older;
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
willing to provide written informed consent;
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
must have uncontrolled hypertension defined as: currently untreated with a diastolic blood pressure greater than 110 mmhg or currently receiving antihypertensive monotherapy with a diastolic blood pressure greater than 100 mmhg. monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy;
Descrição

Uncontrolled hypertension | Diastolic blood pressure | Antihypertensive therapy | Antihypertensive Agent | Combined Modality Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0585941
UMLS CUI [4]
C0003364
UMLS CUI [5]
C0009429
must be willing to discontinue antihypertensive medication, if applicable;
Descrição

Antihypertensive Agents Discontinue Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized.
Descrição

Childbearing Potential Contraceptive methods | Low risk pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0404841
wocbp must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.
Descrição

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding;
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known or suspected secondary hypertension;
Descrição

Secondary hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0155616
hypertension emergencies or stroke within the past 12 months;
Descrição

Hypertensive emergency | Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0745136
UMLS CUI [2]
C0038454
heart attack, angina or bypass surgery within the past 6 months;
Descrição

Myocardial Infarction | Angina Pectoris | Bypass Surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002962
UMLS CUI [3]
C1536078
significant kidney disease;
Descrição

Kidney Disease Significant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0750502
significant liver disease;
Descrição

Liver disease Significant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0750502
systemic lupus erythematosus;
Descrição

Lupus Erythematosus, Systemic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024141
gastrointestinal disease or surgery that may interfere with drug absorption;
Descrição

Gastrointestinal Disease Interferes with drug absorption | Gastrointestinal Surgical Procedure Interferes with drug absorption

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0524722
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0678745
cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin;
Descrição

Malignant Neoplasms | Squamous cell carcinoma Localized | Basal cell carcinoma Localized

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C0392752
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C0392752
currently pregnant or lactating;
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study;
Descrição

Mental disorder Study Protocol Comprehension Unable | Cerebral disorder Study Protocol Comprehension Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0234387
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C1299582
drug or alcohol abuse within the last five years;
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
known allergy to irbesartan or diuretics.
Descrição

Hypersensitivity irbesartan | Hypersensitivity Diuretics

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0288171
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0012798
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Similar models

Eligibility Hypertension NCT00095394

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ages 18 and older;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing to provide written informed consent;
boolean
C0021430 (UMLS CUI [1])
Uncontrolled hypertension | Diastolic blood pressure | Antihypertensive therapy | Antihypertensive Agent | Combined Modality Therapy
Item
must have uncontrolled hypertension defined as: currently untreated with a diastolic blood pressure greater than 110 mmhg or currently receiving antihypertensive monotherapy with a diastolic blood pressure greater than 100 mmhg. monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy;
boolean
C1868885 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
C0003364 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
Antihypertensive Agents Discontinue Willing
Item
must be willing to discontinue antihypertensive medication, if applicable;
boolean
C0003364 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Low risk pregnancy
Item
women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0404841 (UMLS CUI [2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
wocbp must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Secondary hypertension
Item
known or suspected secondary hypertension;
boolean
C0155616 (UMLS CUI [1])
Hypertensive emergency | Cerebrovascular accident
Item
hypertension emergencies or stroke within the past 12 months;
boolean
C0745136 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Myocardial Infarction | Angina Pectoris | Bypass Surgery
Item
heart attack, angina or bypass surgery within the past 6 months;
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C1536078 (UMLS CUI [3])
Kidney Disease Significant
Item
significant kidney disease;
boolean
C0022658 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Liver disease Significant
Item
significant liver disease;
boolean
C0023895 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Lupus Erythematosus, Systemic
Item
systemic lupus erythematosus;
boolean
C0024141 (UMLS CUI [1])
Gastrointestinal Disease Interferes with drug absorption | Gastrointestinal Surgical Procedure Interferes with drug absorption
Item
gastrointestinal disease or surgery that may interfere with drug absorption;
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0524722 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0678745 (UMLS CUI [2,3])
Malignant Neoplasms | Squamous cell carcinoma Localized | Basal cell carcinoma Localized
Item
cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin;
boolean
C0006826 (UMLS CUI [1])
C0007137 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C0392752 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
currently pregnant or lactating;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorder Study Protocol Comprehension Unable | Cerebral disorder Study Protocol Comprehension Unable
Item
mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study;
boolean
C0004936 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0234387 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
Substance Use Disorders
Item
drug or alcohol abuse within the last five years;
boolean
C0038586 (UMLS CUI [1])
Hypersensitivity irbesartan | Hypersensitivity Diuretics
Item
known allergy to irbesartan or diuretics.
boolean
C0020517 (UMLS CUI [1,1])
C0288171 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0012798 (UMLS CUI [2,2])
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