ID

29899

Description

Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301); ODM derived from: https://clinicaltrials.gov/show/NCT00446524

Lien

https://clinicaltrials.gov/show/NCT00446524

Mots-clés

Versions (1)
  1. 26/04/2018 26/04/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

26 avril 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Hypertension NCT00446524

Anglais

Eligibility Hypertension NCT00446524

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who successfully complete the core study (study cvaa489a1301.
Description

Clinical Trial Successful Completed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1272703
UMLS CUI [1,3]
C0205197
patients whose blood pressure at visit 7 of the study cvaa489a1301 had to be well controlled defined as msdbp < 90 mmhg and mssbp < 140 mmhg. at the investigator's or sub-investigator's discretion, those patients who were not well controlled (msdbp ≥
Description

Blood Pressure Well controlled | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C3853142
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
90 mmhg or mssbp ≥ 140 mmhg), and whose msdbp was < 100 mmhg and mssbp was < 160 mmhg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.
Description

Blood Pressure Poorly controlled | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
male or female outpatients.
Description

Outpatients

Type de données

boolean

Alias
UMLS CUI [1]
C0029921
patients who have written informed consent to participate in this study.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of major protocol violation in study cvaa489a1301.
Description

Protocol Violation Major

Type de données

boolean

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C0205164
patients who experienced any adverse events considered serious and drug related in study cvaa489a1301.
Description

Serious Adverse Event | Adverse reaction to drug

Type de données

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0041755
patients who experienced any adverse events considered serious and drug related in study cvaa489a1301.
Description

Serious Adverse Event | Adverse reaction to drug

Type de données

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0041755
patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.
Description

Protocol Compliance Unlikely

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
patients who have gout or gouty arthritis.
Description

Gout | Arthritis, Gouty

Type de données

boolean

Alias
UMLS CUI [1]
C0018099
UMLS CUI [2]
C0003868
patients hypersensitive to diuretics (except for potassium sparing diuretics).
Description

Diuretic allergy | Exception Potassium Sparing Diuretics

Type de données

boolean

Alias
UMLS CUI [1]
C0571893
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0304490
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Type de données

boolean

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

Eligibility Hypertension NCT00446524

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Successful Completed
Item
patients who successfully complete the core study (study cvaa489a1301.
boolean
C0008976 (UMLS CUI [1,1])
C1272703 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Blood Pressure Well controlled | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
patients whose blood pressure at visit 7 of the study cvaa489a1301 had to be well controlled defined as msdbp < 90 mmhg and mssbp < 140 mmhg. at the investigator's or sub-investigator's discretion, those patients who were not well controlled (msdbp ≥
boolean
C0005823 (UMLS CUI [1,1])
C3853142 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Blood Pressure Poorly controlled | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
90 mmhg or mssbp ≥ 140 mmhg), and whose msdbp was < 100 mmhg and mssbp was < 160 mmhg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.
boolean
C0005823 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Outpatients
Item
male or female outpatients.
boolean
C0029921 (UMLS CUI [1])
Informed Consent
Item
patients who have written informed consent to participate in this study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Protocol Violation Major
Item
presence of major protocol violation in study cvaa489a1301.
boolean
C1709750 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Serious Adverse Event | Adverse reaction to drug
Item
patients who experienced any adverse events considered serious and drug related in study cvaa489a1301.
boolean
C1519255 (UMLS CUI [1])
C0041755 (UMLS CUI [2])
Serious Adverse Event | Adverse reaction to drug
Item
patients who experienced any adverse events considered serious and drug related in study cvaa489a1301.
boolean
C1519255 (UMLS CUI [1])
C0041755 (UMLS CUI [2])
Protocol Compliance Unlikely
Item
patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Gout | Arthritis, Gouty
Item
patients who have gout or gouty arthritis.
boolean
C0018099 (UMLS CUI [1])
C0003868 (UMLS CUI [2])
Diuretic allergy | Exception Potassium Sparing Diuretics
Item
patients hypersensitive to diuretics (except for potassium sparing diuretics).
boolean
C0571893 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0304490 (UMLS CUI [2,2])
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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