ID

29899

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00446524

Nyckelord

Versioner (1)
  1. 2018-04-26 2018-04-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT00446524

Engelsk

Eligibility Hypertension NCT00446524

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Clinical Trial Successful Completed

Datatyp

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 ≥
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Outpatients

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Protocol Violation Major

Datatyp

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.
Beskrivning

Serious Adverse Event | Adverse reaction to drug

Datatyp

boolean

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

Serious Adverse Event | Adverse reaction to drug

Datatyp

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.
Beskrivning

Protocol Compliance Unlikely

Datatyp

boolean

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

Gout | Arthritis, Gouty

Datatyp

boolean

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

Diuretic allergy | Exception Potassium Sparing Diuretics

Datatyp

boolean

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

Eligibility Criteria Study Protocol

Datatyp

boolean

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

Eligibility Hypertension NCT00446524

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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