ID

36151

Beschreibung

REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02499822

Link

https://clinicaltrials.gov/show/NCT02499822

Stichworte

Versionen (1)
  1. 17.04.19 17.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. April 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Hypertension NCT02499822

Englisch

Eligibility Hypertension NCT02499822

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
age 35-75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
clinic systolic bp ≥140 mmhg and/or diastolic bp ≥ 90 mmhg (under no antihypertensive treatment)
Beschreibung

Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3,1]
C0585941
UMLS CUI [3,2]
C0332197
daytime bp on ambulatory bp monitoring (abpm) ≥135 mmhg systolic and/or ≥85 mmhg diastolic (under no antihypertensive treatment)
Beschreibung

Ambulatory Blood Pressure Monitoring Daytime | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242876
UMLS CUI [1,2]
C0332169
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0585941
UMLS CUI [4,2]
C0332197
home sbp standard deviation (sd) >7 mmhg and/or daytime ambulatory sbp sd >12 mmhg
Beschreibung

Systolic Pressure Standard deviation | Ambulatory Blood Pressure Monitoring Systolic Pressure Standard deviation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0871420
UMLS CUI [2,1]
C0242876
UMLS CUI [2,2]
C0871470
UMLS CUI [2,3]
C0871420
patients may be included if untreated or, if treated with one antihypertensive drug or two drugs in low doses, after 2 weeks' washout period
Beschreibung

Patients Untreated | Antihypertensive Agents Quantity | Antihypertensive Agents Low dose Quantity | Status post Washout Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0445550
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1710661
written informed consent to participate in the study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects treated with ≥ 2 antihypertensive drugs (except those on two drugs in low doses)
Beschreibung

Antihypertensive Agents Quantity | Exception Antihypertensive Agents Quantity Low dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003364
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0445550
treated subjects with on-treatment clinic bp ≥160 mmhg systolic and/or 100 mmhg diastolic
Beschreibung

Study Subject Treated | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1522326
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
Beschreibung

Antihypertensive therapy Discontinuation Unacceptable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1883420
contraindications to study treatments as detailed in the relative summaries of medical product characteristics for ramipril (hypersensitivity to ramipril or any of the excipients or any other ace inhibitor, history of angioneurotic oedema, extracorporeal treatments leading to contact of blood with negatively charged surfaces, significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, second and third trimesters of pregnancy, lactation, haemodynamically relevant renal artery stenosis, hypotensive or haemodynamically unstable patients) or nifedipine gits (known hypersensitivity to nifedipine or to any of the excipients, pregnancy before week 20 and during breastfeeding, cardiovascular shock, concomitant treatment with rifampicin, patients with a kock pouch)
Beschreibung

Medical contraindication Investigational Therapy | Ramipril allergy | Hypersensitivity Ramipril Excipient | Angiotensin-converting-enzyme inhibitor allergy | Angioedema | Therapeutic procedure Extracorporeal At risk | Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Functioning Solitary | Pregnancy Second Trimester | Pregnancy Third Trimester | Breast Feeding | Renal Artery Stenosis | Patients Hypotensive | Hemodynamic instability | Other Coding | Nifedipine allergy | Hypersensitivity Nifedipine Excipient | Shock, Cardiogenic | Rifampin | Kock Pouch

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0949266
UMLS CUI [2]
C0571943
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0072973
UMLS CUI [3,3]
C0015237
UMLS CUI [4]
C0571939
UMLS CUI [5]
C0002994
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0442087
UMLS CUI [6,3]
C1444641
UMLS CUI [7]
C0856760
UMLS CUI [8,1]
C0035067
UMLS CUI [8,2]
C0022646
UMLS CUI [8,3]
C0542341
UMLS CUI [8,4]
C0205171
UMLS CUI [9]
C0032980
UMLS CUI [10]
C0032981
UMLS CUI [11]
C0006147
UMLS CUI [12]
C0035067
UMLS CUI [13,1]
C0030705
UMLS CUI [13,2]
C0857353
UMLS CUI [14]
C0948268
UMLS CUI [15]
C3846158
UMLS CUI [16]
C0570915
UMLS CUI [17,1]
C0020517
UMLS CUI [17,2]
C0028066
UMLS CUI [17,3]
C0015237
UMLS CUI [18]
C0036980
UMLS CUI [19]
C0035608
UMLS CUI [20]
C0086512
cardiovascular diseases other than hypertension (coronary heart disease, heart failure or left ventricular systolic dysfunction of any degree, atrial fibrillation or frequent arrhythmias, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, aortic aneurysm)
Beschreibung

Cardiovascular Diseases | Exception Hypertensive disease | Coronary heart disease | Heart failure | Left ventricular systolic dysfunction Degree Any | Atrial Fibrillation | Cardiac Arrhythmia Frequent | Heart valve disease | Congenital heart disease | Cardiomyopathy | Cerebrovascular Disorders | Peripheral Arterial Diseases | Aortic Aneurysm

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020538
UMLS CUI [3]
C0010068
UMLS CUI [4]
C0018801
UMLS CUI [5,1]
C1277187
UMLS CUI [5,2]
C0441889
UMLS CUI [5,3]
C1552551
UMLS CUI [6]
C0004238
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0332183
UMLS CUI [8]
C0018824
UMLS CUI [9]
C0152021
UMLS CUI [10]
C0878544
UMLS CUI [11]
C0007820
UMLS CUI [12]
C1704436
UMLS CUI [13]
C0003486
chronic kidney disease
Beschreibung

Chronic Kidney Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1561643
suspected or confirmed secondary hypertension
Beschreibung

Secondary hypertension Suspected | Secondary hypertension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0155616
diabetes mellitus
Beschreibung

Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
subjects with conditions other than those mentioned above, where compelling indications for the use of any specific class of antihypertensive medication exist, according to current (e.g. european society of cardiology) guidelines
Beschreibung

Indication Antihypertensive Agents Specific

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0003364
UMLS CUI [1,3]
C0205369
other conditions deemed relevant by the investigator (including respiratory disorders, liver disease, renal disease, thyroid disorders)
Beschreibung

Other medical condition Relevant | Respiration Disorders | Liver diseases | Kidney Diseases | Thyroid Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2347946
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0040128
bmi ≥35 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
known severe obstructive sleep apnea (apnea-hypopnea index > 30 or use of cpap)
Beschreibung

Obstructive Sleep Apnea Severe | Apnea-hypopnea index | Continuous Positive Airway Pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0520679
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2111846
UMLS CUI [3]
C0199451
premenopausal women not using effective contraceptive methods
Beschreibung

Premenopausal state Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
elevated probability of noncompliance with the study procedures
Beschreibung

Protocol Compliance Unlikely

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hypertension NCT02499822

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
male and female subjects
boolean
C0079399 (UMLS CUI [1])
Age
Item
age 35-75 years
boolean
C0001779 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Absent
Item
clinic systolic bp ≥140 mmhg and/or diastolic bp ≥ 90 mmhg (under no antihypertensive treatment)
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0585941 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Ambulatory Blood Pressure Monitoring Daytime | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Absent
Item
daytime bp on ambulatory bp monitoring (abpm) ≥135 mmhg systolic and/or ≥85 mmhg diastolic (under no antihypertensive treatment)
boolean
C0242876 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0585941 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Systolic Pressure Standard deviation | Ambulatory Blood Pressure Monitoring Systolic Pressure Standard deviation
Item
home sbp standard deviation (sd) >7 mmhg and/or daytime ambulatory sbp sd >12 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C0871420 (UMLS CUI [1,2])
C0242876 (UMLS CUI [2,1])
C0871470 (UMLS CUI [2,2])
C0871420 (UMLS CUI [2,3])
Patients Untreated | Antihypertensive Agents Quantity | Antihypertensive Agents Low dose Quantity | Status post Washout Period
Item
patients may be included if untreated or, if treated with one antihypertensive drug or two drugs in low doses, after 2 weeks' washout period
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3,1])
C0445550 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C1710661 (UMLS CUI [4,2])
Informed Consent
Item
written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Quantity | Exception Antihypertensive Agents Quantity Low dose
Item
subjects treated with ≥ 2 antihypertensive drugs (except those on two drugs in low doses)
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003364 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0445550 (UMLS CUI [2,4])
Study Subject Treated | Systolic Pressure | Diastolic blood pressure
Item
treated subjects with on-treatment clinic bp ≥160 mmhg systolic and/or 100 mmhg diastolic
boolean
C0681850 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Antihypertensive therapy Discontinuation Unacceptable
Item
treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
boolean
C0585941 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1883420 (UMLS CUI [1,3])
Medical contraindication Investigational Therapy | Ramipril allergy | Hypersensitivity Ramipril Excipient | Angiotensin-converting-enzyme inhibitor allergy | Angioedema | Therapeutic procedure Extracorporeal At risk | Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Functioning Solitary | Pregnancy Second Trimester | Pregnancy Third Trimester | Breast Feeding | Renal Artery Stenosis | Patients Hypotensive | Hemodynamic instability | Other Coding | Nifedipine allergy | Hypersensitivity Nifedipine Excipient | Shock, Cardiogenic | Rifampin | Kock Pouch
Item
contraindications to study treatments as detailed in the relative summaries of medical product characteristics for ramipril (hypersensitivity to ramipril or any of the excipients or any other ace inhibitor, history of angioneurotic oedema, extracorporeal treatments leading to contact of blood with negatively charged surfaces, significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, second and third trimesters of pregnancy, lactation, haemodynamically relevant renal artery stenosis, hypotensive or haemodynamically unstable patients) or nifedipine gits (known hypersensitivity to nifedipine or to any of the excipients, pregnancy before week 20 and during breastfeeding, cardiovascular shock, concomitant treatment with rifampicin, patients with a kock pouch)
boolean
C1301624 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C0571943 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0072973 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0571939 (UMLS CUI [4])
C0002994 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C0442087 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0856760 (UMLS CUI [7])
C0035067 (UMLS CUI [8,1])
C0022646 (UMLS CUI [8,2])
C0542341 (UMLS CUI [8,3])
C0205171 (UMLS CUI [8,4])
C0032980 (UMLS CUI [9])
C0032981 (UMLS CUI [10])
C0006147 (UMLS CUI [11])
C0035067 (UMLS CUI [12])
C0030705 (UMLS CUI [13,1])
C0857353 (UMLS CUI [13,2])
C0948268 (UMLS CUI [14])
C3846158 (UMLS CUI [15])
C0570915 (UMLS CUI [16])
C0020517 (UMLS CUI [17,1])
C0028066 (UMLS CUI [17,2])
C0015237 (UMLS CUI [17,3])
C0036980 (UMLS CUI [18])
C0035608 (UMLS CUI [19])
C0086512 (UMLS CUI [20])
Cardiovascular Diseases | Exception Hypertensive disease | Coronary heart disease | Heart failure | Left ventricular systolic dysfunction Degree Any | Atrial Fibrillation | Cardiac Arrhythmia Frequent | Heart valve disease | Congenital heart disease | Cardiomyopathy | Cerebrovascular Disorders | Peripheral Arterial Diseases | Aortic Aneurysm
Item
cardiovascular diseases other than hypertension (coronary heart disease, heart failure or left ventricular systolic dysfunction of any degree, atrial fibrillation or frequent arrhythmias, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, aortic aneurysm)
boolean
C0007222 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0020538 (UMLS CUI [2,2])
C0010068 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C1277187 (UMLS CUI [5,1])
C0441889 (UMLS CUI [5,2])
C1552551 (UMLS CUI [5,3])
C0004238 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C0332183 (UMLS CUI [7,2])
C0018824 (UMLS CUI [8])
C0152021 (UMLS CUI [9])
C0878544 (UMLS CUI [10])
C0007820 (UMLS CUI [11])
C1704436 (UMLS CUI [12])
C0003486 (UMLS CUI [13])
Chronic Kidney Disease
Item
chronic kidney disease
boolean
C1561643 (UMLS CUI [1])
Secondary hypertension Suspected | Secondary hypertension
Item
suspected or confirmed secondary hypertension
boolean
C0155616 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0155616 (UMLS CUI [2])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Indication Antihypertensive Agents Specific
Item
subjects with conditions other than those mentioned above, where compelling indications for the use of any specific class of antihypertensive medication exist, according to current (e.g. european society of cardiology) guidelines
boolean
C3146298 (UMLS CUI [1,1])
C0003364 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Other medical condition Relevant | Respiration Disorders | Liver diseases | Kidney Diseases | Thyroid Diseases
Item
other conditions deemed relevant by the investigator (including respiratory disorders, liver disease, renal disease, thyroid disorders)
boolean
C3843040 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0035204 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0040128 (UMLS CUI [5])
Body mass index
Item
bmi ≥35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Obstructive Sleep Apnea Severe | Apnea-hypopnea index | Continuous Positive Airway Pressure
Item
known severe obstructive sleep apnea (apnea-hypopnea index > 30 or use of cpap)
boolean
C0520679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2111846 (UMLS CUI [2])
C0199451 (UMLS CUI [3])
Premenopausal state Contraceptive methods Absent
Item
premenopausal women not using effective contraceptive methods
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Protocol Compliance Unlikely
Item
elevated probability of noncompliance with the study procedures
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video