ID

38648

Description

A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril; ODM derived from: https://clinicaltrials.gov/show/NCT01398267

Link

https://clinicaltrials.gov/show/NCT01398267

Keywords

  1. 10/29/19 10/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 29, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT01398267

Eligibility Diabetes Mellitus, Type 2 NCT01398267

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult male and female patients, 18 to 65 years of age, inclusive
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
diabetes mellitus type 2, diagnosed at least 3 months before screening
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treated with stable dose of metformin for at least 4 weeks prior to screening
Description

Metformin Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
treated with stable dose of angiotensin-converting enzyme inhibitor (acei) for at least 4 weeks prior to screening
Description

Angiotensin-Converting Enzyme Inhibitors Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
body mass index (bmi) 18 to 38 kg/m2, inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive for hiv-1, hiv-2, hepatitis b or hepatitis c infection
Description

HIV-1 infection | HIV-2 infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C2363741
UMLS CUI [2]
C0854094
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
pregnant or lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
type 1 diabetes or secondary from of diabetes
Description

Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0271640
history or evidence of proliferative diabetic retinopathy or clinically significant neuropathy
Description

Proliferative diabetic retinopathy | Neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0154830
UMLS CUI [2]
C0442874
clinically significant hepatic disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
clinically significant renal impairment
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
history or evidence of clinically significant cardio-vascular disease or disorder
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
acute infection or current malignancy requiring treatment except for excised basal cell carcinoma
Description

Communicable Disease Treatment required for | Malignant Neoplasms Treatment required for | Exception Excision Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0728940
UMLS CUI [3,3]
C0007117

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01398267

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult male and female patients, 18 to 65 years of age, inclusive
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diabetes mellitus type 2, diagnosed at least 3 months before screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin Dose Stable
Item
treated with stable dose of metformin for at least 4 weeks prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Angiotensin-Converting Enzyme Inhibitors Dose Stable
Item
treated with stable dose of angiotensin-converting enzyme inhibitor (acei) for at least 4 weeks prior to screening
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) 18 to 38 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV-1 infection | HIV-2 infection | Hepatitis B | Hepatitis C
Item
positive for hiv-1, hiv-2, hepatitis b or hepatitis c infection
boolean
C2363741 (UMLS CUI [1])
C0854094 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus
Item
type 1 diabetes or secondary from of diabetes
boolean
C0011854 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
Proliferative diabetic retinopathy | Neuropathy
Item
history or evidence of proliferative diabetic retinopathy or clinically significant neuropathy
boolean
C0154830 (UMLS CUI [1])
C0442874 (UMLS CUI [2])
Liver disease
Item
clinically significant hepatic disease
boolean
C0023895 (UMLS CUI [1])
Renal Insufficiency
Item
clinically significant renal impairment
boolean
C1565489 (UMLS CUI [1])
Cardiovascular Disease
Item
history or evidence of clinically significant cardio-vascular disease or disorder
boolean
C0007222 (UMLS CUI [1])
Communicable Disease Treatment required for | Malignant Neoplasms Treatment required for | Exception Excision Basal cell carcinoma
Item
acute infection or current malignancy requiring treatment except for excised basal cell carcinoma
boolean
C0009450 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0728940 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])

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