ID

32695

Description

Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases); ODM derived from: https://clinicaltrials.gov/show/NCT00549757

Link

https://clinicaltrials.gov/show/NCT00549757

Keywords

Versions (1)
  1. 11/12/18 11/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00549757

English

Eligibility Type 2 Diabetes Mellitus NCT00549757

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes and at least one of the following:
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
macroalbuminuria and an egfr ≥30 ml/min/1.73 m2
Description

Macroalbuminuria | eGFR

Data type

boolean

Alias
UMLS CUI [1]
C1654921
UMLS CUI [2]
C3811844
microalbuminuria and a reduced kidney function (egfr egfr ≥30 and <60 ml/min/1.73 m2)
Description

Microalbuminuria | Renal Insufficiency | eGFR

Data type

boolean

Alias
UMLS CUI [1]
C0730345
UMLS CUI [2]
C1565489
UMLS CUI [3]
C3811844
a history of cv disease (previous mi, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (egfr ≥30 and <60 ml/min/1.73 m2)
Description

Cardiovascular Disease | Myocardial Infarction | Cerebrovascular accident | Heart failure | Coronary Artery Disease | Percutaneous Coronary Intervention | Stenosis Percent Coronary artery Quantity | Angiography | Renal Insufficiency | eGFR

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0018801
UMLS CUI [5]
C1956346
UMLS CUI [6]
C1532338
UMLS CUI [7,1]
C1261287
UMLS CUI [7,2]
C0439165
UMLS CUI [7,3]
C0205042
UMLS CUI [7,4]
C1265611
UMLS CUI [8]
C0002978
UMLS CUI [9]
C1565489
UMLS CUI [10]
C3811844
concomitant treatment should follow national guidelines and must include either an angiotensin-converting-enzyme-inhibitor (acei) or an angiotensin-receptor-blocker (arb) but not both.
Description

Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
cardiovascular event or procedure ≤ 3 months prior to visit 1
Description

Cardiovascular event | Cardiovascular procedure

Data type

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0189573
unstable serum creatinine
Description

Serum creatinine Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0600061
UMLS CUI [1,2]
C0443343
hypertension: mean sitting systolic blood pressure (mssbp) ≥ 135 and < 170 mmhg or mean sitting diastolic blood pressure (msdbp) ≥ 85 and < 110 mmhg unless treated with at least 3 anti-hypertensive medications
Description

Hypertensive disease | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Exception Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0003364
UMLS CUI [4,3]
C1265611
hypertension mssbp ≥ 170 or msdbp ≥ 110 mmhg
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
baseline serum potassium > 5.0 mmol/l
Description

Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0302353
patients who are treated with two renin-angiotensin-aldosterone-system-blockers
Description

Renin-Angiotensin-Aldosterone System Antagonists Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0086907
UMLS CUI [1,2]
C0243076
UMLS CUI [1,3]
C1265611
patients with nyha class iii or iv heart failure
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
known renal artery stenosis
Description

Renal Artery Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0035067
previous randomization into the avoid trial (cspp100c2201)
Description

Study Subject Participation Status | Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
exclusion specific to the safety follow-up period:
Description

Exclusion Criteria Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C3274571
aliskiren or aliskiren containing fixed combination products must not be used
Description

Aliskiren | Combination Product Containing Aliskiren

Data type

boolean

Alias
UMLS CUI [1]
C1120110
UMLS CUI [2,1]
C1880146
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C1120110
other protocol-defined inclusion/exclusion criteria applied
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00549757

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes and at least one of the following:
boolean
C0011860 (UMLS CUI [1])
Macroalbuminuria | eGFR
Item
macroalbuminuria and an egfr ≥30 ml/min/1.73 m2
boolean
C1654921 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Microalbuminuria | Renal Insufficiency | eGFR
Item
microalbuminuria and a reduced kidney function (egfr egfr ≥30 and <60 ml/min/1.73 m2)
boolean
C0730345 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C3811844 (UMLS CUI [3])
Cardiovascular Disease | Myocardial Infarction | Cerebrovascular accident | Heart failure | Coronary Artery Disease | Percutaneous Coronary Intervention | Stenosis Percent Coronary artery Quantity | Angiography | Renal Insufficiency | eGFR
Item
a history of cv disease (previous mi, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (egfr ≥30 and <60 ml/min/1.73 m2)
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C1956346 (UMLS CUI [5])
C1532338 (UMLS CUI [6])
C1261287 (UMLS CUI [7,1])
C0439165 (UMLS CUI [7,2])
C0205042 (UMLS CUI [7,3])
C1265611 (UMLS CUI [7,4])
C0002978 (UMLS CUI [8])
C1565489 (UMLS CUI [9])
C3811844 (UMLS CUI [10])
Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
concomitant treatment should follow national guidelines and must include either an angiotensin-converting-enzyme-inhibitor (acei) or an angiotensin-receptor-blocker (arb) but not both.
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Cardiovascular event | Cardiovascular procedure
Item
cardiovascular event or procedure ≤ 3 months prior to visit 1
boolean
C1320716 (UMLS CUI [1])
C0189573 (UMLS CUI [2])
Serum creatinine Unstable
Item
unstable serum creatinine
boolean
C0600061 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Hypertensive disease | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Exception Antihypertensive Agents Quantity
Item
hypertension: mean sitting systolic blood pressure (mssbp) ≥ 135 and < 170 mmhg or mean sitting diastolic blood pressure (msdbp) ≥ 85 and < 110 mmhg unless treated with at least 3 anti-hypertensive medications
boolean
C0020538 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0003364 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Hypertensive disease | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
hypertension mssbp ≥ 170 or msdbp ≥ 110 mmhg
boolean
C0020538 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Serum potassium measurement
Item
baseline serum potassium > 5.0 mmol/l
boolean
C0302353 (UMLS CUI [1])
Renin-Angiotensin-Aldosterone System Antagonists Quantity
Item
patients who are treated with two renin-angiotensin-aldosterone-system-blockers
boolean
C0086907 (UMLS CUI [1,1])
C0243076 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Heart failure New York Heart Association Classification
Item
patients with nyha class iii or iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Renal Artery Stenosis
Item
known renal artery stenosis
boolean
C0035067 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial Specified
Item
previous randomization into the avoid trial (cspp100c2201)
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Exclusion Criteria Follow-up
Item
exclusion specific to the safety follow-up period:
boolean
C0680251 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Aliskiren | Combination Product Containing Aliskiren
Item
aliskiren or aliskiren containing fixed combination products must not be used
boolean
C1120110 (UMLS CUI [1])
C1880146 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C1120110 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria applied
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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