ID

29338

Beschrijving

A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00667719

Link

https://clinicaltrials.gov/show/NCT00667719

Trefwoorden

Versies (1)
  1. 19-03-18 19-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 maart 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT00667719

Engels

Eligibility Essential Hypertension NCT00667719

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients 18 years of age or older
Beschrijving

Outpatients | Age

Datatype

boolean

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

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
msdbp & mssbp requirements:
Beschrijving

Sitting diastolic blood pressure mean Requirement | Sitting systolic blood pressure mean Requirement

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C1514873
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C1514873
for newly diagnosed/untreated patients, msdbp ≥ 100 and < 120 mmhg, and/or mssbp
Beschrijving

Patients Newly Diagnosed | Patients untreated | Sitting diastolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
≥ 160 and < 200 mmhg at visit 1 and visit 2.
Beschrijving

Patients Newly Diagnosed | Patients untreated | Sitting systolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
for previously treated patients, msdbp ≥ 100 and < 120 mmhg, and/or mssbp ≥ 160 and < 200 mmhg at visit 2, visit 3, or visit 4.
Beschrijving

Prior Therapy | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
for patients requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.
Beschrijving

Patient need for Antihypertensive Agents Tapering | Antihypertensive therapy To be stopped

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003364
UMLS CUI [1,3]
C0441640
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C1272691
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).
Beschrijving

Patient eligible for clinical trial | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C1302261
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to discontinue all prior antihypertensive medications safely for a period of 1 week to 4 weeks as required by the protocol.
Beschrijving

Antihypertensive Agents Unable to discontinue

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1548265
patients on three antihypertensive drugs with msdbp ≥ 110 mmhg and/or mssbp ≥ 180 mmhg at visit 1.
Beschrijving

Antihypertensive Agents Quantity | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
patients on four or more antihypertensive drugs at visit 1.
Beschrijving

Antihypertensive Agents Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
patients with an mssbp ≥ 200 and msdbp ≥ 120 mmhg anytime during the washout period of the study visit 1-4 must be discontinued from the study.
Beschrijving

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (>= 5 miu/ml).
Beschrijving

Pregnancy | HCG pregnancy test Positive | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0546577
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0006147
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Eligibility Essential Hypertension NCT00667719

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
outpatients 18 years of age or older
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender
Item
male or female patients are eligible.
boolean
C0079399 (UMLS CUI [1])
Sitting diastolic blood pressure mean Requirement | Sitting systolic blood pressure mean Requirement
Item
msdbp & mssbp requirements:
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Patients Newly Diagnosed | Patients untreated | Sitting diastolic blood pressure mean
Item
for newly diagnosed/untreated patients, msdbp ≥ 100 and < 120 mmhg, and/or mssbp
boolean
C0030705 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Patients Newly Diagnosed | Patients untreated | Sitting systolic blood pressure mean
Item
≥ 160 and < 200 mmhg at visit 1 and visit 2.
boolean
C0030705 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Prior Therapy | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
for previously treated patients, msdbp ≥ 100 and < 120 mmhg, and/or mssbp ≥ 160 and < 200 mmhg at visit 2, visit 3, or visit 4.
boolean
C1514463 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Patient need for Antihypertensive Agents Tapering | Antihypertensive therapy To be stopped
Item
for patients requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.
boolean
C0686904 (UMLS CUI [1,1])
C0003364 (UMLS CUI [1,2])
C0441640 (UMLS CUI [1,3])
C0585941 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Patient eligible for clinical trial | 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
C1302261 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Unable to discontinue
Item
inability to discontinue all prior antihypertensive medications safely for a period of 1 week to 4 weeks as required by the protocol.
boolean
C0003364 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
Antihypertensive Agents Quantity | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
patients on three antihypertensive drugs with msdbp ≥ 110 mmhg and/or mssbp ≥ 180 mmhg at visit 1.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Antihypertensive Agents Quantity
Item
patients on four or more antihypertensive drugs at visit 1.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
patients with an mssbp ≥ 200 and msdbp ≥ 120 mmhg anytime during the washout period of the study visit 1-4 must be discontinued from the study.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Pregnancy | HCG pregnancy test Positive | Breast Feeding
Item
pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (>= 5 miu/ml).
boolean
C0032961 (UMLS CUI [1])
C0546577 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
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