Informações:
Falhas:
ID
21062
Descrição
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.; ODM derived from: https://clinicaltrials.gov/show/NCT00386607
Link
https://clinicaltrials.gov/show/NCT00386607
Palavras-chave
Versões (1)
- 06/04/2017 06/04/2017 -
Transferido a
6 de abril de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hypertension NCT00386607
Eligibility Hypertension NCT00386607
- StudyEvent: Eligibility
Similar models
Eligibility Hypertension NCT00386607
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Outpatients | Age
Item
male and female outpatients 18 years of age and older.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Essential Hypertension Newly Diagnosed | Essential Hypertension Untreated
Item
for newly diagnosed/untreated patients with essential hypertension defined as msdbp ≥
boolean
C0085580 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0085580 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C1518321 (UMLS CUI [1,2])
C0085580 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Sitting diastolic blood pressure mean
Item
90 and < 110 mmhg at visit 1 and visit 4
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,2])
Essential Hypertension Treated | Sitting diastolic blood pressure mean
Item
for previously treated patients with essential hypertension defined as msdbp ≥ 90 and < 110 mmhg after 2 to 4 weeks of washout (visit 4)
boolean
C0085580 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1522326 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Study Subject Participation Status | Informed Consent
Item
patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).
boolean
C2348568 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [2])
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
severe hypertension (msdbp ≥ 110 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])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Childbearing Potential | Postmenopausal state | Childbearing Potential Contraceptive methods
Item
women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
boolean
C3831118 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (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
Item
history of hypertensive encephalopathy or cerebrovascular accident.
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0038454 (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])
C2348563 (UMLS CUI [1,2])