ID

29338

Description

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

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 NCT00667719

English

Eligibility Essential Hypertension NCT00667719

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients 18 years of age or older
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
msdbp & mssbp requirements:
Description

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

Data type

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
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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).
Description

Patient eligible for clinical trial | Informed Consent

Data type

boolean

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

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.
Description

Antihypertensive Agents Unable to discontinue

Data type

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.
Description

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

Data type

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.
Description

Antihypertensive Agents Quantity

Data type

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.
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Data type

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).
Description

Pregnancy | HCG pregnancy test Positive | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0546577
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0006147
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Similar models

Eligibility Essential Hypertension NCT00667719

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 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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