ID

39239

Description

Perindopril Amlodipine for the Treatment of Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01556997

Link

https://clinicaltrials.gov/show/NCT01556997

Keywords

Versions (1)
  1. 12/11/19 12/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01556997

English

Eligibility Essential Hypertension NCT01556997

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
essential hypertension
Description

Essential Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0085580
for female subjects, a negative serum pregnancy test
Description

Gender Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430061
ability to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
night shift workers whose work hours include midnight to 4:00 a.m.
Description

Night shift worker

Data type

boolean

Alias
UMLS CUI [1]
C0555008
secondary hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
an arm size that precludes the use of the digital blood pressure monitor cuff (arm size > 42 cm)
Description

Arm size | Use of Blood Pressure Monitor with Cuff Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1140618
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C1949887
UMLS CUI [2,3]
C0332196
renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects
Description

Renal dysfunction | Renal Insufficiency Severe | Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Solitary | Patients Kidney Quantity | Status post Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0856760
UMLS CUI [4,1]
C0035067
UMLS CUI [4,2]
C0022646
UMLS CUI [4,3]
C0205171
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C0022646
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C0022671
female subjects who are pregnant, planning to become pregnant
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
history of malignancy within 5 years
Description

History of malignant neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0455471
primary aldosteronism
Description

Primary aldosteronism

Data type

boolean

Alias
UMLS CUI [1]
C1719312
heart failure (nyha functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve
Description

Heart failure New York Heart Association Classification | Hypertrophic Cardiomyopathy | Aortic Valve Stenosis Relevance Hemodynamic | Mitral Valve Stenosis Relevance Hemodynamic

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0007194
UMLS CUI [3,1]
C0003507
UMLS CUI [3,2]
C2347946
UMLS CUI [3,3]
C0019010
UMLS CUI [4,1]
C0026269
UMLS CUI [4,2]
C2347946
UMLS CUI [4,3]
C0019010
significant cardiac arrhythmias, mi, stroke, cabg, ptca, unstable angina
Description

Cardiac Arrhythmia | Myocardial Infarction | Cerebrovascular accident | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0010055
UMLS CUI [5]
C2936173
UMLS CUI [6]
C0002965
known hypersensitivity to any component of the study drugs
Description

Hypersensitivity Investigational New Drug Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Essential Hypertension NCT01556997

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension
Item
essential hypertension
boolean
C0085580 (UMLS CUI [1])
Gender Serum pregnancy test negative
Item
for female subjects, a negative serum pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Informed Consent
Item
ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Night shift worker
Item
night shift workers whose work hours include midnight to 4:00 a.m.
boolean
C0555008 (UMLS CUI [1])
Secondary hypertension
Item
secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Arm size | Use of Blood Pressure Monitor with Cuff Excluded
Item
an arm size that precludes the use of the digital blood pressure monitor cuff (arm size > 42 cm)
boolean
C1140618 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C1949887 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Renal dysfunction | Renal Insufficiency Severe | Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Solitary | Patients Kidney Quantity | Status post Kidney Transplantation
Item
renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects
boolean
C3279454 (UMLS CUI [1])
C1565489 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0856760 (UMLS CUI [3])
C0035067 (UMLS CUI [4,1])
C0022646 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C0022646 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0231290 (UMLS CUI [6,1])
C0022671 (UMLS CUI [6,2])
Pregnancy | Pregnancy, Planned
Item
female subjects who are pregnant, planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
History of malignant neoplasm
Item
history of malignancy within 5 years
boolean
C0455471 (UMLS CUI [1])
Primary aldosteronism
Item
primary aldosteronism
boolean
C1719312 (UMLS CUI [1])
Heart failure New York Heart Association Classification | Hypertrophic Cardiomyopathy | Aortic Valve Stenosis Relevance Hemodynamic | Mitral Valve Stenosis Relevance Hemodynamic
Item
heart failure (nyha functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0007194 (UMLS CUI [2])
C0003507 (UMLS CUI [3,1])
C2347946 (UMLS CUI [3,2])
C0019010 (UMLS CUI [3,3])
C0026269 (UMLS CUI [4,1])
C2347946 (UMLS CUI [4,2])
C0019010 (UMLS CUI [4,3])
Cardiac Arrhythmia | Myocardial Infarction | Cerebrovascular accident | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Angina, Unstable
Item
significant cardiac arrhythmias, mi, stroke, cabg, ptca, unstable angina
boolean
C0003811 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C2936173 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
Hypersensitivity Investigational New Drug Component
Item
known hypersensitivity to any component of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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