ID

30050

Description

Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00542269

Link

https://clinicaltrials.gov/show/NCT00542269

Keywords

Versions (1)
  1. 5/5/18 5/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension With Metabolic Syndrome NCT00542269

English

Eligibility Hypertension With Metabolic Syndrome NCT00542269

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients 18-75 years of age.
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
male or female patients are eligible.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
patients with a diagnosis of hypertension:
Description

Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1]
C0020538
newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a mean sitting systolic blood pressure (mssbp) > 150 mmhg and < 180 mmhg at visit 1.
Description

Patients Newly Diagnosed | Antihypertensive therapy Absent | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
patients treated with antihypertensive monotherapy must have a mssbp ≥ 140 mmhg and <180 mmhg at visit 1.
Description

Antihypertensive therapy | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
patients taking amlodipine monotherapy mssbp > 140 mmhg and < 180 mmhg at visit 1.
Description

Amlodipine | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0051696
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
all patients must have a mssbp ≥ 140 mmhg and < 180 mmhg at visit 3, the end of the amlodipine run-in period.
Description

Patients All | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0444868
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
metabolic syndrome.
Description

Metabolic Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0524620
patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written inform consent form).
Description

Study Subject Participation Status eligible | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548635
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension (office cuff msdbp ≥ 115 mmhg and/or mssbp ≥ 180 mmhg).
Description

Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
history or evidence of a secondary form of hypertension.
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
history of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (tia), myocardial infarction, 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
serum sodium < 135 mmol/l at visit 1 if confirmed on repeat sample.
Description

Serum sodium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0523891
serum potassium < 3.5 mmol/l or ≥ 5.3 mmol/l at visit 1, if confirmed on repeat sample.
Description

Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0302353
type 1 diabetes mellitus.
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
type 2 diabetes if oral hypoglycaemic therapy changed (dose change or medication change) in previous 3 months.
Description

Diabetes Mellitus, Non-Insulin-Dependent | ORAL HYPOGLYCEMIC TREATMENT Changed | Drug dosage altered | Change of medication

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0747045
UMLS CUI [2,2]
C0392747
UMLS CUI [3]
C0420247
UMLS CUI [4]
C0580105
pregnant or nursing (lactating) women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other protocol-defined inclusion/exclusion criteria applied to the study.
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 Hypertension With Metabolic Syndrome NCT00542269

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
outpatients 18-75 years of age.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender
Item
male or female patients are eligible.
boolean
C0079399 (UMLS CUI [1])
Hypertensive disease
Item
patients with a diagnosis of hypertension:
boolean
C0020538 (UMLS CUI [1])
Patients Newly Diagnosed | Antihypertensive therapy Absent | Sitting systolic blood pressure mean
Item
newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a mean sitting systolic blood pressure (mssbp) > 150 mmhg and < 180 mmhg at visit 1.
boolean
C0030705 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0585941 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Antihypertensive therapy | Sitting systolic blood pressure mean
Item
patients treated with antihypertensive monotherapy must have a mssbp ≥ 140 mmhg and <180 mmhg at visit 1.
boolean
C0585941 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Amlodipine | Sitting systolic blood pressure mean
Item
patients taking amlodipine monotherapy mssbp > 140 mmhg and < 180 mmhg at visit 1.
boolean
C0051696 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Patients All | Sitting systolic blood pressure mean
Item
all patients must have a mssbp ≥ 140 mmhg and < 180 mmhg at visit 3, the end of the amlodipine run-in period.
boolean
C0030705 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Metabolic Syndrome
Item
metabolic syndrome.
boolean
C0524620 (UMLS CUI [1])
Study Subject Participation Status eligible | Informed Consent
Item
patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written inform consent form).
boolean
C2348568 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
severe hypertension (office cuff msdbp ≥ 115 mmhg and/or mssbp ≥ 180 mmhg).
boolean
C4013784 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Secondary hypertension
Item
history or evidence of a secondary form of hypertension.
boolean
C0155616 (UMLS CUI [1])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
history of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (tia), myocardial infarction, 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 sodium measurement
Item
serum sodium < 135 mmol/l at visit 1 if confirmed on repeat sample.
boolean
C0523891 (UMLS CUI [1])
Serum potassium measurement
Item
serum potassium < 3.5 mmol/l or ≥ 5.3 mmol/l at visit 1, if confirmed on repeat sample.
boolean
C0302353 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | ORAL HYPOGLYCEMIC TREATMENT Changed | Drug dosage altered | Change of medication
Item
type 2 diabetes if oral hypoglycaemic therapy changed (dose change or medication change) in previous 3 months.
boolean
C0011860 (UMLS CUI [1])
C0747045 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0420247 (UMLS CUI [3])
C0580105 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria applied to the study.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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