ID

38800

Description

Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents; ODM derived from: https://clinicaltrials.gov/show/NCT01939496

Link

https://clinicaltrials.gov/show/NCT01939496

Keywords

Versions (1)
  1. 11/5/19 11/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01939496

English

Eligibility Diabetes Mellitus, Type 2 NCT01939496

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a diagnosis of type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
patients with hypertension (seated office sbp of >=130 mmhg and <160 mmhg and seated office dbp of >= 70 mmhg at screening and at week -2
Description

Hypertensive disease | Sitting systolic blood pressure | Sitting diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C1319893
UMLS CUI [3]
C1319894
patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
Description

Antihypertensive Agents Quantity | Antihypertensive Agents Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening
Description

Oral hypoglycemic Quantity | Oral hypoglycemic Dose Stable | Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0025598
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of diabetic ketoacidosis
Description

Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011880
type 1 diabetes mellitus (t1dm)
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
pancreas or beta-cell transplantation
Description

Pancreas Transplantation | Beta Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0030275
UMLS CUI [2,1]
C0030281
UMLS CUI [2,2]
C0040732
fasting c-peptide <0.70 ng/ml (0.23 nmol/l)
Description

Fasting C-peptide level

Data type

boolean

Alias
UMLS CUI [1]
C2208720
body mass index <30 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
has ongoing, inadequately controlled thyroid disorder
Description

Thyroid Disease Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C3853134
has a history of cardio-renal disease that required treatment with immunosuppressive therapy.
Description

Cardiorenal disease Requirement Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C0155601
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01939496

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with a diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hypertensive disease | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
patients with hypertension (seated office sbp of >=130 mmhg and <160 mmhg and seated office dbp of >= 70 mmhg at screening and at week -2
boolean
C0020538 (UMLS CUI [1])
C1319893 (UMLS CUI [2])
C1319894 (UMLS CUI [3])
Antihypertensive Agents Quantity | Antihypertensive Agents Dose Stable
Item
patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Oral hypoglycemic Quantity | Oral hypoglycemic Dose Stable | Metformin
Item
patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Diabetic Ketoacidosis
Item
a history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus (t1dm)
boolean
C0011854 (UMLS CUI [1])
Pancreas Transplantation | Beta Cell Transplantation
Item
pancreas or beta-cell transplantation
boolean
C0030275 (UMLS CUI [1])
C0030281 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
Fasting C-peptide level
Item
fasting c-peptide <0.70 ng/ml (0.23 nmol/l)
boolean
C2208720 (UMLS CUI [1])
Body mass index
Item
body mass index <30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Thyroid Disease Poorly controlled
Item
has ongoing, inadequately controlled thyroid disorder
boolean
C0040128 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Cardiorenal disease Requirement Therapeutic immunosuppression
Item
has a history of cardio-renal disease that required treatment with immunosuppressive therapy.
boolean
C0155601 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
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