ID

39223

Descrição

Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01413048

Link

https://clinicaltrials.gov/show/NCT01413048

Palavras-chave

Versões (1)
  1. 11/12/2019 11/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01413048

Inglês

Eligibility Essential Hypertension NCT01413048

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients ≥ 19 years of age
Descrição

Outpatients | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
mild to moderate essential hypertension: sdbp 90 ~ 109, ssbp 140 ~ 179
Descrição

Essential Hypertension Mild | Essential Hypertension Moderate | Sitting diastolic blood pressure | Sitting systolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C1319894
UMLS CUI [4]
C1319893
subjects who agree to participate in this sudy and give written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
Descrição

Comprehension Study Protocol | Cooperative Behavior | Follow-up Able

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0009964
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C0085732
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the sitting dbp is more than 110mmhg or the sitting sbp over 180mmhg
Descrição

Sitting diastolic blood pressure | Sitting systolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1319894
UMLS CUI [2]
C1319893
patients with postural hypotension
Descrição

Hypotension, Orthostatic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020651
patients with severe renal(creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(ast, alt more 3 times more than upper limit of normal)disease
Descrição

Kidney Disease Severe | Creatinine measurement, serum | Gastrointestinal Disease Severe | Hematological Disease Severe | Liver disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0151904
UMLS CUI [7]
C0151905
female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
Descrição

Childbearing Potential Hysterectomy Absent | Childbearing Potential Postmenopausal state Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0020699
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0232970
UMLS CUI [2,3]
C0332197
patients judged to have a history of alcohol or drug abuse by the investigator
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
Descrição

Myocardial Infarction | Coronary Artery Disease Severe | Heart failure | Valvular defects

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0018801
UMLS CUI [4]
C2748945
patients with uncontrolled diabetes mellitus
Descrição

Diabetic - poor control

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0421258
patients participated other clinical trial 12 weeks before screening patients judged to be inappropriate for this study by the investigator with other reasons
Descrição

Study Subject Participation Status | Clinical Trial | Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C1548788
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Similar models

Eligibility Essential Hypertension NCT01413048

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male or female outpatients ≥ 19 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Essential Hypertension Mild | Essential Hypertension Moderate | Sitting diastolic blood pressure | Sitting systolic blood pressure
Item
mild to moderate essential hypertension: sdbp 90 ~ 109, ssbp 140 ~ 179
boolean
C0085580 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0085580 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3])
C1319893 (UMLS CUI [4])
Informed Consent
Item
subjects who agree to participate in this sudy and give written informed consent
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Cooperative Behavior | Follow-up Able
Item
subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0009964 (UMLS CUI [2])
C3274571 (UMLS CUI [3,1])
C0085732 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Sitting diastolic blood pressure | Sitting systolic blood pressure
Item
the sitting dbp is more than 110mmhg or the sitting sbp over 180mmhg
boolean
C1319894 (UMLS CUI [1])
C1319893 (UMLS CUI [2])
Hypotension, Orthostatic
Item
patients with postural hypotension
boolean
C0020651 (UMLS CUI [1])
Kidney Disease Severe | Creatinine measurement, serum | Gastrointestinal Disease Severe | Hematological Disease Severe | Liver disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
patients with severe renal(creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(ast, alt more 3 times more than upper limit of normal)disease
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0017178 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0151904 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
Childbearing Potential Hysterectomy Absent | Childbearing Potential Postmenopausal state Absent
Item
female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
boolean
C3831118 (UMLS CUI [1,1])
C0020699 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Substance Use Disorders
Item
patients judged to have a history of alcohol or drug abuse by the investigator
boolean
C0038586 (UMLS CUI [1])
Myocardial Infarction | Coronary Artery Disease Severe | Heart failure | Valvular defects
Item
patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
boolean
C0027051 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3])
C2748945 (UMLS CUI [4])
Diabetic - poor control
Item
patients with uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial | Study Subject Participation Status Inappropriate
Item
patients participated other clinical trial 12 weeks before screening patients judged to be inappropriate for this study by the investigator with other reasons
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
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