ID

20790

Description

Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.; ODM derived from: https://clinicaltrials.gov/show/NCT00343551

Link

https://clinicaltrials.gov/show/NCT00343551

Keywords

Versions (1)
  1. 3/17/17 3/17/17 -
Uploaded on

March 17, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT00343551

English

Eligibility Essential Hypertension NCT00343551

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients 18 years of age and older.
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients must meet following blood pressure criteria:
Description

Blood Pressure criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0243161
at visit 2 : office mean sitting diastolic blood pressure ≥ 90 mmhg and < 110 mmhg at visit 3 : office mean sitting diastolic blood pressure ≥ 95 mmhg and < 110 mmhg before application of ambulatory blood pressure measurement device at visit 3 : 24-hr mean ambulatory diastolic blood pressure ≥ 85 mmhg
Description

Sitting diastolic blood pressure mean | Sphygmomanometers Blood pressure ambulatory | Diastolic blood pressure Ambulatory mean Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0183427
UMLS CUI [2,2]
C0855316
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0439841
UMLS CUI [3,3]
C0444504
UMLS CUI [3,4]
C0449238
patient must have an absolute difference of ≤ 10 mmhg in their office mean sitting diastolic blood pressure between visit 2 and 3.
Description

Sitting diastolic blood pressure mean | Difference Absolute Quantity Visit Number

Data type

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1705242
UMLS CUI [2,2]
C0205344
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1549755
male or female patients are eligible. female patients must be either post-menopausal for at least one year, surgically sterile or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
Description

Gender | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Contraceptives, Oral | Contraception, Barrier | Vaginal Spermicides | Intrauterine Devices

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0009905
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0021900
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 informed consent).
Description

Study Subject Participation Status | Informed Consent

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension [office mean sitting diastolic blood pressure ≥ 110 mmhg and/or office mean sitting systolic blood pressure (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
current diagnosis of heart failure (nyha class ii-iv).
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
history of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci) during the 12 months prior to visit 1.
Description

Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
known or suspected contraindications to the study medications, including history of allergy to ace-inhibitors or arbs.
Description

Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs | allergy to angiotensin converting enzyme inhibitor | Allergy to angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3]
C1319912
UMLS CUI [4]
C2585204
upper arm circumference > 42 cm.
Description

Upper arm Circumference

Data type

boolean

Alias
UMLS CUI [1,1]
C0446516
UMLS CUI [1,2]
C0332520
third shift or night workers.
Description

Shift worker | Night shift worker

Data type

boolean

Alias
UMLS CUI [1]
C0425104
UMLS CUI [2]
C0555008
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 NCT00343551

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
outpatients 18 years of age and older.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Blood Pressure criteria
Item
patients must meet following blood pressure criteria:
boolean
C0005823 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Sitting diastolic blood pressure mean | Sphygmomanometers Blood pressure ambulatory | Diastolic blood pressure Ambulatory mean Duration
Item
at visit 2 : office mean sitting diastolic blood pressure ≥ 90 mmhg and < 110 mmhg at visit 3 : office mean sitting diastolic blood pressure ≥ 95 mmhg and < 110 mmhg before application of ambulatory blood pressure measurement device at visit 3 : 24-hr mean ambulatory diastolic blood pressure ≥ 85 mmhg
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0183427 (UMLS CUI [2,1])
C0855316 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3,1])
C0439841 (UMLS CUI [3,2])
C0444504 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
Sitting diastolic blood pressure mean | Difference Absolute Quantity Visit Number
Item
patient must have an absolute difference of ≤ 10 mmhg in their office mean sitting diastolic blood pressure between visit 2 and 3.
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1705242 (UMLS CUI [2,1])
C0205344 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1549755 (UMLS CUI [2,4])
Gender | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Contraceptives, Oral | Contraception, Barrier | Vaginal Spermicides | Intrauterine Devices
Item
male or female patients are eligible. female patients must be either post-menopausal for at least one year, surgically sterile or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0009905 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
Study Subject Participation Status | 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 informed consent).
boolean
C2348568 (UMLS CUI [1])
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 mean sitting diastolic blood pressure ≥ 110 mmhg and/or office mean sitting systolic blood pressure (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])
Heart failure New York Heart Association Classification
Item
current diagnosis of heart failure (nyha class ii-iv).
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
history of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci) during the 12 months prior to visit 1.
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs | allergy to angiotensin converting enzyme inhibitor | Allergy to angiotensin II receptor antagonist
Item
known or suspected contraindications to the study medications, including history of allergy to ace-inhibitors or arbs.
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1319912 (UMLS CUI [3])
C2585204 (UMLS CUI [4])
Upper arm Circumference
Item
upper arm circumference > 42 cm.
boolean
C0446516 (UMLS CUI [1,1])
C0332520 (UMLS CUI [1,2])
Shift worker | Night shift worker
Item
third shift or night workers.
boolean
C0425104 (UMLS CUI [1])
C0555008 (UMLS CUI [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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