ID

39209

Description

Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01264692

Lien

https://clinicaltrials.gov/show/NCT01264692

Mots-clés

Versions (1)
  1. 10/12/2019 10/12/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

10 décembre 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01264692

Anglais

Eligibility Essential Hypertension NCT01264692

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females aged 18 to 75 years (inclusive) at screening.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
Description

Body mass index | Body Weight

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
12-lead ecg without clinically relevant abnormalities measured at screening.
Description

Abnormality Absent 12 lead ECG

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0430456
clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
Description

Chemistry test Normal | Hematologic Tests Normal | Coagulation test normal | Viral serologic study Normal | Urinalysis results Normal

Type de données

boolean

Alias
UMLS CUI [1,1]
C0201682
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0205307
UMLS CUI [3]
C1504380
UMLS CUI [4,1]
C0201336
UMLS CUI [4,2]
C0205307
UMLS CUI [5,1]
C2097148
UMLS CUI [5,2]
C0205307
signed informed consent in the local language prior to any study-mandated procedure
Description

Informed Consent Language Local

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0023008
UMLS CUI [1,3]
C0205276
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mean sbp > 180 mmhg.
Description

Systolic Pressure mean

Type de données

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
severe, malignant, or secondary hypertension.
Description

Hypertension, severe | Malignant Hypertension | Secondary hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0020540
UMLS CUI [3]
C0155616
episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
Description

Episode of Hypertensive crisis | Hypertensive emergency

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0020546
UMLS CUI [2]
C0745136
previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
Description

History of fainting | Collapse Previous | Syncope Previous | Orthostatic Hypotension Previous | Vasovagal Reaction Previous

Type de données

boolean

Alias
UMLS CUI [1]
C0848811
UMLS CUI [2,1]
C0344329
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0039070
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C0020651
UMLS CUI [4,2]
C0205156
UMLS CUI [5,1]
C1710621
UMLS CUI [5,2]
C0205156
e6 severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
Description

Indication Coronary Artery Disease Severe | Myocardial Infarction | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1956346
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C0027051
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0010055
angina pectoris within 6 months prior to enrollment
Description

Angina Pectoris

Type de données

boolean

Alias
UMLS CUI [1]
C0002962
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Similar models

Eligibility Essential Hypertension NCT01264692

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females aged 18 to 75 years (inclusive) at screening.
boolean
C0001779 (UMLS CUI [1])
Body mass index | Body Weight
Item
body mass index (bmi) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Abnormality Absent 12 lead ECG
Item
12-lead ecg without clinically relevant abnormalities measured at screening.
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Chemistry test Normal | Hematologic Tests Normal | Coagulation test normal | Viral serologic study Normal | Urinalysis results Normal
Item
clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
boolean
C0201682 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C1504380 (UMLS CUI [3])
C0201336 (UMLS CUI [4,1])
C0205307 (UMLS CUI [4,2])
C2097148 (UMLS CUI [5,1])
C0205307 (UMLS CUI [5,2])
Informed Consent Language Local
Item
signed informed consent in the local language prior to any study-mandated procedure
boolean
C0021430 (UMLS CUI [1,1])
C0023008 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure mean
Item
mean sbp > 180 mmhg.
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Hypertension, severe | Malignant Hypertension | Secondary hypertension
Item
severe, malignant, or secondary hypertension.
boolean
C4013784 (UMLS CUI [1])
C0020540 (UMLS CUI [2])
C0155616 (UMLS CUI [3])
Episode of Hypertensive crisis | Hypertensive emergency
Item
episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
boolean
C0332189 (UMLS CUI [1,1])
C0020546 (UMLS CUI [1,2])
C0745136 (UMLS CUI [2])
History of fainting | Collapse Previous | Syncope Previous | Orthostatic Hypotension Previous | Vasovagal Reaction Previous
Item
previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
boolean
C0848811 (UMLS CUI [1])
C0344329 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0039070 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0020651 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C1710621 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
Indication Coronary Artery Disease Severe | Myocardial Infarction | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
e6 severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
boolean
C3146298 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
Angina Pectoris
Item
angina pectoris within 6 months prior to enrollment
boolean
C0002962 (UMLS CUI [1])
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