ID

39958

Beschrijving

Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency; ODM derived from: https://clinicaltrials.gov/show/NCT01172431

Link

https://clinicaltrials.gov/show/NCT01172431

Trefwoorden

Versies (1)
  1. 06-03-20 06-03-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 maart 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT01172431

Engels

Eligibility Hypertension NCT01172431

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
creatinine clearance 30 to 90 ml/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation.
Beschrijving

Creatinine clearance measurement | Variation Percentage Recent

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2,1]
C0205419
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0332185
diagnosed hypertension according to guidelines or having taken anti-hypertension drugs.
Beschrijving

Hypertensive disease | Antihypertensive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0003364
aged between 65 and 85 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
willingness to provide written, informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
ability to adhere to study protocol.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
secondary hypertension.
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
diabetes mellitus.
Beschrijving

Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
atrial flutter/atrial fibrillation.
Beschrijving

Atrial Flutter | Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0004239
UMLS CUI [2]
C0004238
symptoms of congestive heart failure (nyha iii-iv) or there is evidence that left ventricular ef < 40%.
Beschrijving

Symptoms Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0018802
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0428772
recent (< 6 months) myocardial infarction or cerebrovascular ischemic symptoms.
Beschrijving

Myocardial Infarction Recent | Symptoms Cerebral Ischemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0917798
recent (< 3 months) or planned coronary revascularization: pci (percutaneous coronary intervention)/cabg (coronary artery by-pass graft).
Beschrijving

Coronary revascularisation Recent | Coronary revascularisation Planned | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0877341
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0010055
severe valvular heart disease.
Beschrijving

Heart valve disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
history of hypersensitivity to indapamide, thiazides or to any of the components of the products.
Beschrijving

Indapamide allergy | Allergy to thiazides | Hypersensitivity Component Indapamide | Hypersensitivity Component Thiazide

Datatype

boolean

Alias
UMLS CUI [1]
C0571927
UMLS CUI [2]
C0749320
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1705248
UMLS CUI [3,3]
C0021186
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1705248
UMLS CUI [4,3]
C0541746
any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs.
Beschrijving

Condition Interferes with Absorption Investigational New Drugs | Disease Interferes with Absorption Investigational New Drugs | Condition Interferes with Distribution Investigational New Drugs | Disease Interferes with Distribution Investigational New Drugs | Condition Interferes with Metabolism Investigational New Drugs | Disease Interferes with Metabolism Investigational New Drugs | Condition Interferes with Excretion Investigational New Drugs | Disease Interferes with Excretion Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1378698
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1378698
UMLS CUI [4,4]
C0013230
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0025519
UMLS CUI [5,4]
C0013230
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0025519
UMLS CUI [6,4]
C0013230
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0221102
UMLS CUI [7,4]
C0013230
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0221102
UMLS CUI [8,4]
C0013230
participation to another investigational study in the last 3 months.
Beschrijving

Study Subject Participation Status | Research study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0681814
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Similar models

Eligibility Hypertension NCT01172431

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Creatinine clearance measurement | Variation Percentage Recent
Item
creatinine clearance 30 to 90 ml/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation.
boolean
C0373595 (UMLS CUI [1])
C0205419 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Hypertensive disease | Antihypertensive Agents
Item
diagnosed hypertension according to guidelines or having taken anti-hypertension drugs.
boolean
C0020538 (UMLS CUI [1])
C0003364 (UMLS CUI [2])
Age
Item
aged between 65 and 85 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willingness to provide written, informed consent.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
ability to adhere to study protocol.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
secondary hypertension.
boolean
C0155616 (UMLS CUI [1])
Diabetes Mellitus
Item
diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
Atrial Flutter | Atrial Fibrillation
Item
atrial flutter/atrial fibrillation.
boolean
C0004239 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
Symptoms Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction
Item
symptoms of congestive heart failure (nyha iii-iv) or there is evidence that left ventricular ef < 40%.
boolean
C1457887 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2])
Myocardial Infarction Recent | Symptoms Cerebral Ischemia
Item
recent (< 6 months) myocardial infarction or cerebrovascular ischemic symptoms.
boolean
C0027051 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0917798 (UMLS CUI [2,2])
Coronary revascularisation Recent | Coronary revascularisation Planned | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
recent (< 3 months) or planned coronary revascularization: pci (percutaneous coronary intervention)/cabg (coronary artery by-pass graft).
boolean
C0877341 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0877341 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
Heart valve disease Severe
Item
severe valvular heart disease.
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Indapamide allergy | Allergy to thiazides | Hypersensitivity Component Indapamide | Hypersensitivity Component Thiazide
Item
history of hypersensitivity to indapamide, thiazides or to any of the components of the products.
boolean
C0571927 (UMLS CUI [1])
C0749320 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C1705248 (UMLS CUI [3,2])
C0021186 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C1705248 (UMLS CUI [4,2])
C0541746 (UMLS CUI [4,3])
Condition Interferes with Absorption Investigational New Drugs | Disease Interferes with Absorption Investigational New Drugs | Condition Interferes with Distribution Investigational New Drugs | Disease Interferes with Distribution Investigational New Drugs | Condition Interferes with Metabolism Investigational New Drugs | Disease Interferes with Metabolism Investigational New Drugs | Condition Interferes with Excretion Investigational New Drugs | Disease Interferes with Excretion Investigational New Drugs
Item
any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1378698 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1378698 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0025519 (UMLS CUI [5,3])
C0013230 (UMLS CUI [5,4])
C0012634 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0025519 (UMLS CUI [6,3])
C0013230 (UMLS CUI [6,4])
C0348080 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0221102 (UMLS CUI [7,3])
C0013230 (UMLS CUI [7,4])
C0012634 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0221102 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
Study Subject Participation Status | Research study
Item
participation to another investigational study in the last 3 months.
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2])
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