ID

17253

Beschrijving

Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea; ODM derived from: https://clinicaltrials.gov/show/NCT00328965

Link

https://clinicaltrials.gov/show/NCT00328965

Trefwoorden

Versies (1)
  1. 02-09-16 02-09-16 -
Geüploaded op

2 september 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00328965

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00328965

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed as essential hypertension or not treated in the past 2 weeks(if the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week -2) assessments)
Beschrijving

Essential Hypertension | Pharmaceutical Preparations | Washout Period

Datatype

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2]
C0013227
UMLS CUI [3]
C1710661
mean seated sbp at screen visit = 130mmhg (as measured by a mercury sphygmomanometer)
Beschrijving

Systolic Pressure mean | Mercury sphygmomanometer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
UMLS CUI [2]
C0183432
type 2 diabetes (american diabetes association criteria 2004) and hba1c <11%
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0019018
agree to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken if the subject a female of child-bearing potential
Beschrijving

Childbearing Potential Contraceptive methods | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0013230
provide written informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
mean seated sbp of > 180 mmhg
Beschrijving

Systolic Pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
known or suspected secondary hypertension
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
anemia defined by haemoglobin concentration < 10.0 g/dl
Beschrijving

Anemia | Hemoglobin concentration result

Datatype

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0019029
hemoglobinopathy or peripheral vascular disease
Beschrijving

Hemoglobinopathy | Peripheral Vascular Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0085096
clinically significant renal or hepatic disease (i.e., subjects with serum creatinine = 2.0 mg/dl; alanine aminotransferase, aspartate aminotransferase, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal reference range)
Beschrijving

Kidney Disease Clinical Significance | Liver disease Clinical Significance | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement | Alkaline phosphatase measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C2826293
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201913
UMLS CUI [7]
C0201850
unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment
Beschrijving

Angina, Unstable | Angina Pectoris Severe | Coronary artery insufficiency | Congestive heart failure Requirement Pharmacotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0542052
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0013216
chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e. only use of topical, inhaled or nasal corticosteroids is permissible)
Beschrijving

Chronic disease Requirement Therapeutic procedure Intermittent | Chronic disease Requirement Therapeutic procedure chronic | Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous | Intraarticular Corticosteroid Therapy | Topical corticosteroids | inhaled steroids | Adrenal Cortex Hormones Nasal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0205267
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0205191
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C1522726
UMLS CUI [5]
C4054701
UMLS CUI [6]
C0304604
UMLS CUI [7]
C2065041
UMLS CUI [8,1]
C0001617
UMLS CUI [8,2]
C1522019
female who is lactating, pregnant, or planning to become pregnant
Beschrijving

Breast Feeding | Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory tests, or electrocardiogram etc.)
Beschrijving

Abnormality Clinically Significant Indicator Study Subject Participation Status Limited | Physical Examination | Laboratory Procedures | Electrocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0439801
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0022885
UMLS CUI [4]
C1623258
acute or chronic metabolic acidosis or a history of diabetic ketoacidosis
Beschrijving

Metabolic acidosis | Chronic metabolic acidosis | Diabetic Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0740749
UMLS CUI [3]
C0011880
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00328965

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension | Pharmaceutical Preparations | Washout Period
Item
newly diagnosed as essential hypertension or not treated in the past 2 weeks(if the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week -2) assessments)
boolean
C0085580 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
C1710661 (UMLS CUI [3])
Systolic Pressure mean | Mercury sphygmomanometer
Item
mean seated sbp at screen visit = 130mmhg (as measured by a mercury sphygmomanometer)
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0183432 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Glycosylated hemoglobin A
Item
type 2 diabetes (american diabetes association criteria 2004) and hba1c <11%
boolean
C0011860 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Investigational New Drugs
Item
agree to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken if the subject a female of child-bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Informed consent
Item
provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure mean
Item
mean seated sbp of > 180 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Secondary hypertension
Item
known or suspected secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Anemia | Hemoglobin concentration result
Item
anemia defined by haemoglobin concentration < 10.0 g/dl
boolean
C0002871 (UMLS CUI [1])
C0019029 (UMLS CUI [2])
Hemoglobinopathy | Peripheral Vascular Disease
Item
hemoglobinopathy or peripheral vascular disease
boolean
C0019045 (UMLS CUI [1])
C0085096 (UMLS CUI [2])
Kidney Disease Clinical Significance | Liver disease Clinical Significance | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement | Alkaline phosphatase measurement
Item
clinically significant renal or hepatic disease (i.e., subjects with serum creatinine = 2.0 mg/dl; alanine aminotransferase, aspartate aminotransferase, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal reference range)
boolean
C0022658 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201913 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
Angina, Unstable | Angina Pectoris Severe | Coronary artery insufficiency | Congestive heart failure Requirement Pharmacotherapy
Item
unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0542052 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0013216 (UMLS CUI [4,3])
Chronic disease Requirement Therapeutic procedure Intermittent | Chronic disease Requirement Therapeutic procedure chronic | Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous | Intraarticular Corticosteroid Therapy | Topical corticosteroids | inhaled steroids | Adrenal Cortex Hormones Nasal
Item
chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e. only use of topical, inhaled or nasal corticosteroids is permissible)
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205267 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
C0001617 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C1522726 (UMLS CUI [4,2])
C4054701 (UMLS CUI [5])
C0304604 (UMLS CUI [6])
C2065041 (UMLS CUI [7])
C0001617 (UMLS CUI [8,1])
C1522019 (UMLS CUI [8,2])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
female who is lactating, pregnant, or planning to become pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Abnormality Clinically Significant Indicator Study Subject Participation Status Limited | Physical Examination | Laboratory Procedures | Electrocardiography
Item
clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory tests, or electrocardiogram etc.)
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0031809 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
Metabolic acidosis | Chronic metabolic acidosis | Diabetic Ketoacidosis
Item
acute or chronic metabolic acidosis or a history of diabetic ketoacidosis
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
C0011880 (UMLS CUI [3])
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