ID

19412

Beschrijving

Renal and Systemic Effects of NCX4016 in Patients With Type 2 Diabetes and Early Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00157508

Link

https://clinicaltrials.gov/show/NCT00157508

Trefwoorden

Versies (1)
  1. 30-12-16 30-12-16 -
Geüploaded op

30 december 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00157508

Engels

Eligibility Type 2 Diabetes NCT00157508

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients affected by type 2 diabetes with stable metabolic control (hba1c < 9%), and stable systemic blood pressure control (sbp/ dbp < 160/90 mmhg).
Beschrijving

Gender | Diabetes Mellitus, Non-Insulin-Dependent | Metabolic Control Stable | Glucohemoglobin measurement | Regulation of systemic arterial blood pressure Stable | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C1513158
UMLS CUI [3,2]
C0205360
UMLS CUI [4]
C0202054
UMLS CUI [5,1]
C2256440
UMLS CUI [5,2]
C0205360
UMLS CUI [6]
C0871470
UMLS CUI [7]
C0428883
presence of early nephropathy (overnight albumin excretion rate > 20 microg/ min for at least 6 months), without overt renal insufficiency (serum creatinine concentration < 2 mg/dl).
Beschrijving

Kidney Disease Early | Overnight albumin excretion rate Duration | Renal Insufficiency | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C1279919
UMLS CUI [2,1]
C1272175
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0201976
age between 18 and 75 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
written signed informed consent; patient willing and able to comply with all study procedures and scheduled visits.
Beschrijving

Informed Consent | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of any form of allergic reactions or hypersensitivity or intolerance or contraindication to acetylsalicylic acid or nitrates.
Beschrijving

Allergic Reaction Aspirin | Hypersensitivity Aspirin | intolerance to Aspirin | Medical contraindication Aspirin | Allergic Reaction Nitrates | Hypersensitivity Nitrates | intolerance to Nitrates | Medical contraindication Nitrates

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0004057
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0004057
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0004057
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0028125
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0028125
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0028125
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0028125
patients under the age of 18 or above 75.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients who are not able to give an informed consent or inadequate comprehension of study risks and requirements.
Beschrijving

Informed Consent Unable | Study Protocol Comprehension Inadequate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C0205412
patients who are unable to comply with the requirements of the study protocol.
Beschrijving

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
chronic alcohol or drug abuse (current or within the past year).
Beschrijving

Substance Use Disorders chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0205191
pregnancy and lactation.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
if women of child-bearing potential, a pregnancy test must be performed before inclusion and after the study, and reliable contraceptive methods followed.
Beschrijving

Childbearing Potential Pregnancy Test | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
evidence for non-diabetic renal disease.
Beschrijving

Kidney Disease Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0332120
patients with duodenal/gastric ulcer history, or gastrointestinal bleeding over the last 6 months.
Beschrijving

Duodenal Ulcer | Gastric ulcer | Gastrointestinal Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0013295
UMLS CUI [2]
C0038358
UMLS CUI [3]
C0017181
patients with liver insufficiency (asat, alat > 2 times the upper normal limit).
Beschrijving

Hepatic Insufficiency | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
patients with platelet counts < 100,000 cells/mm3.
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
patients with hemorrhagic diathesis.
Beschrijving

Bleeding tendency

Datatype

boolean

Alias
UMLS CUI [1]
C1458140
patients on antiinflammatory or immunosuppressive therapy over the last 6 months.
Beschrijving

Antiinflammatory therapy | Therapeutic immunosuppression

Datatype

boolean

Alias
UMLS CUI [1]
C1096024
UMLS CUI [2]
C0021079
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Similar models

Eligibility Type 2 Diabetes NCT00157508

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Diabetes Mellitus, Non-Insulin-Dependent | Metabolic Control Stable | Glucohemoglobin measurement | Regulation of systemic arterial blood pressure Stable | Systolic Pressure | Diastolic blood pressure
Item
male and female patients affected by type 2 diabetes with stable metabolic control (hba1c < 9%), and stable systemic blood pressure control (sbp/ dbp < 160/90 mmhg).
boolean
C0079399 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C1513158 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0202054 (UMLS CUI [4])
C2256440 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0871470 (UMLS CUI [6])
C0428883 (UMLS CUI [7])
Kidney Disease Early | Overnight albumin excretion rate Duration | Renal Insufficiency | Creatinine measurement, serum
Item
presence of early nephropathy (overnight albumin excretion rate > 20 microg/ min for at least 6 months), without overt renal insufficiency (serum creatinine concentration < 2 mg/dl).
boolean
C0022658 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C1272175 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C1565489 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Age
Item
age between 18 and 75 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
written signed informed consent; patient willing and able to comply with all study procedures and scheduled visits.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Aspirin | Hypersensitivity Aspirin | intolerance to Aspirin | Medical contraindication Aspirin | Allergic Reaction Nitrates | Hypersensitivity Nitrates | intolerance to Nitrates | Medical contraindication Nitrates
Item
history of any form of allergic reactions or hypersensitivity or intolerance or contraindication to acetylsalicylic acid or nitrates.
boolean
C1527304 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0004057 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
C1527304 (UMLS CUI [5,1])
C0028125 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0028125 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0028125 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0028125 (UMLS CUI [8,2])
Age
Item
patients under the age of 18 or above 75.
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable | Study Protocol Comprehension Inadequate
Item
patients who are not able to give an informed consent or inadequate comprehension of study risks and requirements.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C2348563 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Protocol Compliance Unable
Item
patients who are unable to comply with the requirements of the study protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Substance Use Disorders chronic
Item
chronic alcohol or drug abuse (current or within the past year).
boolean
C0038586 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy and lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Pregnancy Test | Childbearing Potential Contraceptive methods
Item
if women of child-bearing potential, a pregnancy test must be performed before inclusion and after the study, and reliable contraceptive methods followed.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Kidney Disease Evidence of
Item
evidence for non-diabetic renal disease.
boolean
C0022658 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Duodenal Ulcer | Gastric ulcer | Gastrointestinal Hemorrhage
Item
patients with duodenal/gastric ulcer history, or gastrointestinal bleeding over the last 6 months.
boolean
C0013295 (UMLS CUI [1])
C0038358 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
Hepatic Insufficiency | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
patients with liver insufficiency (asat, alat > 2 times the upper normal limit).
boolean
C1306571 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Platelet Count measurement
Item
patients with platelet counts < 100,000 cells/mm3.
boolean
C0032181 (UMLS CUI [1])
Bleeding tendency
Item
patients with hemorrhagic diathesis.
boolean
C1458140 (UMLS CUI [1])
Antiinflammatory therapy | Therapeutic immunosuppression
Item
patients on antiinflammatory or immunosuppressive therapy over the last 6 months.
boolean
C1096024 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
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