ID

17611

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00095394

Keywords

versioni (1)
  1. 26/09/16 26/09/16 -
Caricato su

26 settembre 2016

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Hypertension NCT00095394

Inglese

Eligibility Hypertension NCT00095394

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

Age

Tipo di dati

boolean

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

Informed Consent

Tipo di dati

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;
Descrizione

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

Tipo di dati

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;
Descrizione

Antihypertensive Agents Discontinue Willing

Tipo di dati

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.
Descrizione

Childbearing Potential Contraceptive methods | Low risk pregnancy

Tipo di dati

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.
Descrizione

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

Tipo di dati

boolean

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

Exclusion Criteria

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

Pregnancy | Breast Feeding

Tipo di dati

boolean

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

Secondary hypertension

Tipo di dati

boolean

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

Hypertensive emergency | Cerebrovascular accident

Tipo di dati

boolean

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

Myocardial Infarction | Angina Pectoris | Bypass Surgery

Tipo di dati

boolean

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

Kidney Disease Significant

Tipo di dati

boolean

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

Liver disease Significant

Tipo di dati

boolean

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

Lupus Erythematosus, Systemic

Tipo di dati

boolean

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

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

Tipo di dati

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;
Descrizione

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

Tipo di dati

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;
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

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;
Descrizione

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

Tipo di dati

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;
Descrizione

Substance Use Disorders

Tipo di dati

boolean

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

Hypersensitivity irbesartan | Hypersensitivity Diuretics

Tipo di dati

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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