ID

24436

Description

Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00500604

Link

https://clinicaltrials.gov/show/NCT00500604

Keywords

Versions (2)
  1. 7/31/17 7/31/17 -
  2. 7/31/17 7/31/17 -
Uploaded on

July 31, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00500604

English

Eligibility Hypertension NCT00500604

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
established essential hypertension, untreated or treated but uncontrolled with treatment:
Description

Essential Hypertension Established Untreated | Essential Hypertension Established Treated Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0443211
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C0443211
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C0205318
office sbp ≥ 160 mmhg for untreated patients
Description

Systolic Pressure Patients Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0332155
office sbp ≥ 140 mmhg for patients already treated with an antihypertensive drug.
Description

Systolic Pressure Patients Treated | Antihypertensive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C1522326
UMLS CUI [2]
C0003364
previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:
Description

Antihypertensive therapy Pharmaceutical Preparation Single | Antihypertensive therapy Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205171
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0009429
ace inhibitor / calcium channel blocker
Description

Angiotensin-Converting Enzyme Inhibitors | Calcium Channel Blockers

Data type

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0006684
beta blocker / calcium channel blocker
Description

Adrenergic beta-Antagonists | Calcium Channel Blockers

Data type

boolean

Alias
UMLS CUI [1]
C0001645
UMLS CUI [2]
C0006684
beta blocker / low dose diuretic
Description

Adrenergic beta-Antagonists | Diuretics Low dose

Data type

boolean

Alias
UMLS CUI [1]
C0001645
UMLS CUI [2,1]
C0012798
UMLS CUI [2,2]
C0445550
ace inhibitor / low dose diuretic
Description

Angiotensin-Converting Enzyme Inhibitors | Diuretics Low dose

Data type

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2,1]
C0012798
UMLS CUI [2,2]
C0445550
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
sbp ≥ 180 mmhg and/or dbp ≥ 110 mmhg evaluated at doctor's office at visit 1
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
known or suspected causes of secondary hypertension
Description

Secondary hypertension Causes | Secondary hypertension Causes Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0015127
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0750491
patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
Description

Bilateral renal artery stenosis | Renal Artery Stenosis Single kidney | Kidney Transplantation | Single functional kidney

Data type

boolean

Alias
UMLS CUI [1]
C0856760
UMLS CUI [2,1]
C0035067
UMLS CUI [2,2]
C1849176
UMLS CUI [3]
C0022671
UMLS CUI [4]
C1504368
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the investigator to make participation in the study not in the best interest of the subject
Description

Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Kidney Diseases | Metabolic Diseases | Gastrointestinal Diseases | Malignant Neoplasms | Disease Study Subject Participation Status Unfavorable

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0025517
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0006826
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C3640815
known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin ii receptor antagonist or any combination of the drugs used
Description

Diuretic allergy | Allergy to sulfonamides | Angioedema Associated with Angiotensin II receptor antagonist | Cough Associated with Angiotensin II receptor antagonist | Angioedema Associated with Pharmaceutical Preparations | Cough Associated with Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0571893
UMLS CUI [2]
C0038757
UMLS CUI [3,1]
C0002994
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0521942
UMLS CUI [4,1]
C0010200
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0521942
UMLS CUI [5,1]
C0002994
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0013227
UMLS CUI [6,1]
C0010200
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C0013227
known contraindications to any of the study drugs
Description

Medical contraindication Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
concomitant use of any other antihypertensive treatment
Description

Antihypertensive therapy

Data type

boolean

Alias
UMLS CUI [1]
C0585941
use of any of the investigational products for this study within the 3 months prior to the study
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
inability to obtain a valid hbpm recording i.e., obesity, arm circumference > 32 cm or arrhythmia
Description

Home Blood Pressure Monitoring Unable | Obesity | circumference of arm | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C1449681
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C0028754
UMLS CUI [3]
C2075184
UMLS CUI [4]
C0003811
administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
Description

Childbearing Potential Contraceptive methods Lacking | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Pregnancy Tests Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
UMLS CUI [3,3]
C1299582
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Hypertension NCT00500604

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension Established Untreated | Essential Hypertension Established Treated Uncontrolled
Item
established essential hypertension, untreated or treated but uncontrolled with treatment:
boolean
C0085580 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0085580 (UMLS CUI [2,1])
C0443211 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0205318 (UMLS CUI [2,4])
Systolic Pressure Patients Untreated
Item
office sbp ≥ 160 mmhg for untreated patients
boolean
C0871470 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
Systolic Pressure Patients Treated | Antihypertensive Agents
Item
office sbp ≥ 140 mmhg for patients already treated with an antihypertensive drug.
boolean
C0871470 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2])
Antihypertensive therapy Pharmaceutical Preparation Single | Antihypertensive therapy Combined Modality Therapy
Item
previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:
boolean
C0585941 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C0585941 (UMLS CUI [2,1])
C0009429 (UMLS CUI [2,2])
Angiotensin-Converting Enzyme Inhibitors | Calcium Channel Blockers
Item
ace inhibitor / calcium channel blocker
boolean
C0003015 (UMLS CUI [1])
C0006684 (UMLS CUI [2])
Adrenergic beta-Antagonists | Calcium Channel Blockers
Item
beta blocker / calcium channel blocker
boolean
C0001645 (UMLS CUI [1])
C0006684 (UMLS CUI [2])
Adrenergic beta-Antagonists | Diuretics Low dose
Item
beta blocker / low dose diuretic
boolean
C0001645 (UMLS CUI [1])
C0012798 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
Angiotensin-Converting Enzyme Inhibitors | Diuretics Low dose
Item
ace inhibitor / low dose diuretic
boolean
C0003015 (UMLS CUI [1])
C0012798 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure | Diastolic blood pressure
Item
sbp ≥ 180 mmhg and/or dbp ≥ 110 mmhg evaluated at doctor's office at visit 1
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Secondary hypertension Causes | Secondary hypertension Causes Suspected
Item
known or suspected causes of secondary hypertension
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0155616 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Bilateral renal artery stenosis | Renal Artery Stenosis Single kidney | Kidney Transplantation | Single functional kidney
Item
patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
boolean
C0856760 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C1849176 (UMLS CUI [2,2])
C0022671 (UMLS CUI [3])
C1504368 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Kidney Diseases | Metabolic Diseases | Gastrointestinal Diseases | Malignant Neoplasms | Disease Study Subject Participation Status Unfavorable
Item
significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the investigator to make participation in the study not in the best interest of the subject
boolean
C0007222 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C3640815 (UMLS CUI [8,3])
Diuretic allergy | Allergy to sulfonamides | Angioedema Associated with Angiotensin II receptor antagonist | Cough Associated with Angiotensin II receptor antagonist | Angioedema Associated with Pharmaceutical Preparations | Cough Associated with Pharmaceutical Preparations
Item
known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin ii receptor antagonist or any combination of the drugs used
boolean
C0571893 (UMLS CUI [1])
C0038757 (UMLS CUI [2])
C0002994 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0521942 (UMLS CUI [3,3])
C0010200 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0521942 (UMLS CUI [4,3])
C0002994 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C0010200 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
Medical contraindication Investigational New Drugs
Item
known contraindications to any of the study drugs
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Antihypertensive therapy
Item
concomitant use of any other antihypertensive treatment
boolean
C0585941 (UMLS CUI [1])
Investigational New Drugs
Item
use of any of the investigational products for this study within the 3 months prior to the study
boolean
C0013230 (UMLS CUI [1])
Home Blood Pressure Monitoring Unable | Obesity | circumference of arm | Cardiac Arrhythmia
Item
inability to obtain a valid hbpm recording i.e., obesity, arm circumference > 32 cm or arrhythmia
boolean
C1449681 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0028754 (UMLS CUI [2])
C2075184 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
Investigational New Drugs
Item
administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Lacking | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Pregnancy Tests Unable
Item
women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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