ID

20584

Beschreibung

TELSYS - TELmisartan Effectiveness in Isolated SYStolic Hypertension Versus Systolic/Diastolic Hypertension Patients Aged 55 or Older; ODM derived from: https://clinicaltrials.gov/show/NCT02242877

Link

https://clinicaltrials.gov/show/NCT02242877

Stichworte

Versionen (1)
  1. 04.03.17 04.03.17 -
Hochgeladen am

4. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypertension NCT02242877

Englisch

Eligibility Hypertension NCT02242877

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 55, with no upper limit
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patient who has been treated and followed up for more than 12 months by the same general practitioner (gp)
Beschreibung

General Practitioners; follow-up; Duration (temporal concept)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1522577
UMLS CUI [1,3]
C0449238
hypertension measured at least once during the past 12 months and not under control at the time of inclusion in the study:
Beschreibung

Hypertensive (finding); Medical History

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0857121
UMLS CUI [1,2]
C0262926
isolated systolic hypertension, namely systolic blood pressure ≥ 140 mmhg and diastolic blood pressure < 90 mmhg or
Beschreibung

Isolated systolic hypertension | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0745133
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
systolic/diastolic hypertension, namely systolic blood pressure ≥ 140 mmhg and diastolic blood pressure ≥ 90 mmhg; or
Beschreibung

Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
systolic blood pressure ≥ 130 and diastolic blood pressure ≥ 80 mmhg, if the patient has diabetes or chronic renal insufficiency
Beschreibung

Systolic Pressure | Diastolic blood pressure | Diabetes Mellitus | Chronic Kidney Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0403447
treatment with one or more antihypertensives which remains unchanged during the month prior to collecting the data
Beschreibung

antihypertensive agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003364
decision by the gp to add telmisartan (either in combination with hydrochlorothiazide (hctz) or not) to the antihypertensive treatment; this decision is made by the treating doctor regardless of participation in the study. the prescription is issued in the normal way, in accordance with the conditions set down in the marketing authorisation
Beschreibung

telmisartan | telmisartan; Hydrochlorothiazide; Combined Modality Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0248719
UMLS CUI [2,1]
C0248719
UMLS CUI [2,2]
C0020261
UMLS CUI [2,3]
C0009429
written informed consent of the patient to collect his/her data
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient refuses to allow his/her data to be collected
Beschreibung

limited protocol compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439801
UMLS CUI [1,2]
C0525058
change in the antihypertensive treatment during the month prior to collection of the data
Beschreibung

Antihypertensive Agents; Therapy change

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C3665894
blood pressure under control
Beschreibung

blood pressure normal

Datentyp

boolean

Alias
UMLS CUI [1]
C2712122
the recommended target values corresponding to control of diastolic and systolic blood pressure are important because of the diseases associated with hypertension consequently, and in order to prevent the collection process becoming too complicated, data from patients with severe renal insufficiency or with proteinuria of ≥ 1 g/l or more are not collected in the context of this study
Beschreibung

severe renal insufficiency, proteinuria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0033687
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Ähnliche Modelle

Eligibility Hypertension NCT02242877

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age ≥ 55, with no upper limit
boolean
C0001779 (UMLS CUI [1])
General Practitioners; follow-up; Duration (temporal concept)
Item
patient who has been treated and followed up for more than 12 months by the same general practitioner (gp)
boolean
C0017319 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Hypertensive (finding); Medical History
Item
hypertension measured at least once during the past 12 months and not under control at the time of inclusion in the study:
boolean
C0857121 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Isolated systolic hypertension | Systolic Pressure | Diastolic blood pressure
Item
isolated systolic hypertension, namely systolic blood pressure ≥ 140 mmhg and diastolic blood pressure < 90 mmhg or
boolean
C0745133 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure
Item
systolic/diastolic hypertension, namely systolic blood pressure ≥ 140 mmhg and diastolic blood pressure ≥ 90 mmhg; or
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Systolic Pressure | Diastolic blood pressure | Diabetes Mellitus | Chronic Kidney Insufficiency
Item
systolic blood pressure ≥ 130 and diastolic blood pressure ≥ 80 mmhg, if the patient has diabetes or chronic renal insufficiency
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0403447 (UMLS CUI [4])
antihypertensive agents
Item
treatment with one or more antihypertensives which remains unchanged during the month prior to collecting the data
boolean
C0003364 (UMLS CUI [1])
telmisartan | telmisartan; Hydrochlorothiazide; Combined Modality Therapy
Item
decision by the gp to add telmisartan (either in combination with hydrochlorothiazide (hctz) or not) to the antihypertensive treatment; this decision is made by the treating doctor regardless of participation in the study. the prescription is issued in the normal way, in accordance with the conditions set down in the marketing authorisation
boolean
C0248719 (UMLS CUI [1])
C0248719 (UMLS CUI [2,1])
C0020261 (UMLS CUI [2,2])
C0009429 (UMLS CUI [2,3])
informed consent
Item
written informed consent of the patient to collect his/her data
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
limited protocol compliance
Item
the patient refuses to allow his/her data to be collected
boolean
C0439801 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Antihypertensive Agents; Therapy change
Item
change in the antihypertensive treatment during the month prior to collection of the data
boolean
C0003364 (UMLS CUI [1,1])
C3665894 (UMLS CUI [1,2])
blood pressure normal
Item
blood pressure under control
boolean
C2712122 (UMLS CUI [1])
severe renal insufficiency, proteinuria
Item
the recommended target values corresponding to control of diastolic and systolic blood pressure are important because of the diseases associated with hypertension consequently, and in order to prevent the collection process becoming too complicated, data from patients with severe renal insufficiency or with proteinuria of ≥ 1 g/l or more are not collected in the context of this study
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0033687 (UMLS CUI [2])
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