ID

29336

Description

Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.; ODM derived from: https://clinicaltrials.gov/show/NCT00654875

Link

https://clinicaltrials.gov/show/NCT00654875

Keywords

Versions (1)
  1. 3/19/18 3/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT00654875

English

Eligibility Essential Hypertension NCT00654875

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have diagnosis of uncomplicated essential hypertension; newly diagnosed or who have not received antihypertension medication within 4 weeks of visit 1 must have an office cuff mean sitting diastolic blood pressure (msdbp) > 100 mmhg and < 110 mmhg at visit 1. if patient is receiving antihypertensive treatment, must have a cuff msdbp > 95 mmhg and < 110 mmhg at visit 1
Description

Essential Hypertension Uncomplicated | Antihypertensive Agents Absent | Sitting diastolic blood pressure mean | Relationship Antihypertensive therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0443334
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0585941
prior to randomization, all patients must have an office cuff msdbp >or= 100 mmhg and <or = 110 mmhg.
Description

Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in another aliskiren trial or previous treatment with aliskiren during last 6 months and who qualified to be randomized or enrolled into the active drug treatment period
Description

Study Subject Participation Status | aliskiren

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1120110
pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of child bearing potential unwilling to use protocol specific contraceptive methods
Description

Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
office cuff blood pressure of msdbp ≥ 112 mmhg and/or mean sitting systolic blood pressure (mssbp) ≥ 200 mmhg).
Description

Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
secondary form of hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
history of heart failure new york heart association (nyha class ii, iii and iv)
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
previous history of hypertensive encephalopathy or stroke, transient ischemic attack (tia), heart attack, coronary bypass surgery or any percutaneous coronary intervention (pci)
Description

Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0010055
UMLS CUI [6]
C1532338
elevated serum potassium (> or = 5.3 meq/l (mmol/l) at visit 1
Description

Serum potassium increased

Data type

boolean

Alias
UMLS CUI [1]
C0553704
type 1 or type 2 diabetes mellitus not well controlled
Description

Insulin-Dependent Diabetes Mellitus Poorly controlled | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
other protocol-defined inclusion/exclusion criteria may apply
Description

Clinical Trial 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 Essential Hypertension NCT00654875

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension Uncomplicated | Antihypertensive Agents Absent | Sitting diastolic blood pressure mean | Relationship Antihypertensive therapy
Item
have diagnosis of uncomplicated essential hypertension; newly diagnosed or who have not received antihypertension medication within 4 weeks of visit 1 must have an office cuff mean sitting diastolic blood pressure (msdbp) > 100 mmhg and < 110 mmhg at visit 1. if patient is receiving antihypertensive treatment, must have a cuff msdbp > 95 mmhg and < 110 mmhg at visit 1
boolean
C0085580 (UMLS CUI [1,1])
C0443334 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C0585941 (UMLS CUI [4,2])
Sitting diastolic blood pressure mean
Item
prior to randomization, all patients must have an office cuff msdbp >or= 100 mmhg and <or = 110 mmhg.
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | aliskiren
Item
participation in another aliskiren trial or previous treatment with aliskiren during last 6 months and who qualified to be randomized or enrolled into the active drug treatment period
boolean
C2348568 (UMLS CUI [1])
C1120110 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
women of child bearing potential unwilling to use protocol specific contraceptive methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
office cuff blood pressure of msdbp ≥ 112 mmhg and/or mean sitting systolic blood pressure (mssbp) ≥ 200 mmhg).
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Secondary hypertension
Item
secondary form of hypertension
boolean
C0155616 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
history of heart failure new york heart association (nyha class ii, iii and iv)
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
previous history of hypertensive encephalopathy or stroke, transient ischemic attack (tia), heart attack, coronary bypass surgery or any percutaneous coronary intervention (pci)
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C1532338 (UMLS CUI [6])
Serum potassium increased
Item
elevated serum potassium (> or = 5.3 meq/l (mmol/l) at visit 1
boolean
C0553704 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Poorly controlled | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
type 1 or type 2 diabetes mellitus not well controlled
boolean
C0011854 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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