ID

21062

Description

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

Lien

https://clinicaltrials.gov/show/NCT00386607

Mots-clés

  1. 06/04/2017 06/04/2017 -
Téléchargé le

6 avril 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Hypertension NCT00386607

Eligibility Hypertension NCT00386607

Criteria
Description

Criteria

male and female outpatients 18 years of age and older.
Description

Outpatients | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
for newly diagnosed/untreated patients with essential hypertension defined as msdbp ≥
Description

Essential Hypertension Newly Diagnosed | Essential Hypertension Untreated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C0332155
90 and < 110 mmhg at visit 1 and visit 4
Description

Sitting diastolic blood pressure mean

Type de données

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
for previously treated patients with essential hypertension defined as msdbp ≥ 90 and < 110 mmhg after 2 to 4 weeks of washout (visit 4)
Description

Essential Hypertension Treated | Sitting diastolic blood pressure mean

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
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).
Description

Study Subject Participation Status | Informed Consent

Type de données

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension (msdbp ≥ 110 mmhg and/or mssbp ≥ 180 mmhg)
Description

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

Type de données

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
women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
Description

Childbearing Potential | Postmenopausal state | Childbearing Potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
history or evidence of a secondary form of hypertension.
Description

Secondary hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C0155616
history of hypertensive encephalopathy or cerebrovascular accident.
Description

Hypertensive Encephalopathy | Cerebrovascular accident

Type de données

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
other protocol-defined inclusion/exclusion criteria may apply.
Description

Clinical Trial Eligibility Criteria Study Protocol

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Hypertension NCT00386607

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Outpatients | Age
Item
male and female outpatients 18 years of age and older.
boolean
C0029921 (UMLS CUI [1])
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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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