ID

21049

Description

DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00330369

Lien

https://clinicaltrials.gov/show/NCT00330369

Mots-clés

Versions (1)
  1. 06/04/2017 06/04/2017 -
Téléchargé le

6 avril 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Hypertension NCT00330369

Anglais

Eligibility Hypertension NCT00330369

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who are competent to provide written consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
aged 35 to 80 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmhg
Description

Diabetes Mellitus | Chronic Kidney Diseases | Systolic Pressure mean

Type de données

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C1561643
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0444504
all other subjects must have a mean systolic blood pressure ≥140 mmhg
Description

Study Subject Systolic Pressure mean

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0871470
UMLS CUI [1,3]
C0444504
receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
Description

Antihypertensive Agents Class Different Quantity | Diuretic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C1705242
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0012798
female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)
Description

Gender Childbearing Potential Absent | Postmenopausal state | Female Sterilization

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
average sitting systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg
Description

Sitting systolic blood pressure Average | Sitting diastolic blood pressure Average

Type de données

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C1510992
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C1510992
serum alt or ast >2 x the upper limit of the normal range (uln)
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Type de données

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (cva) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
Description

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Tachyarrhythmia Atrial Recurrent | Recurrent ventricular tachycardia | BRADYCARDIA SYMPTOMATIC

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0037052
UMLS CUI [5]
C0264906
UMLS CUI [6]
C0151517
UMLS CUI [7]
C0004238
UMLS CUI [8,1]
C0080203
UMLS CUI [8,2]
C0018792
UMLS CUI [8,3]
C2945760
UMLS CUI [9]
C1737264
UMLS CUI [10]
C0741627
implanted pacemakers or implanted cardioverter defibrillator (icd)
Description

pacemaker implant | Implantable defibrillator

Type de données

boolean

Alias
UMLS CUI [1]
C0848753
UMLS CUI [2]
C0162589
symptomatic congestive heart failure requiring treatment
Description

Symptomatic congestive heart failure Treatment required for

Type de données

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C0332121
hemodynamically significant valvular heart disease
Description

Heart valve disease Hemodynamic Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
type i diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
hemodialysis or peritoneal dialysis; or history of renal transplant
Description

Hemodialysis | Peritoneal Dialysis | Kidney Transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2]
C0031139
UMLS CUI [3]
C0022671
diagnosis or recurrence of malignancy within the past 3 years
Description

Malignant Neoplasm | Recurrent tumor

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0521158
sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%
Description

Sleep Apnea | Arterial oxygen saturation measurement Sleep study

Type de données

boolean

Alias
UMLS CUI [1]
C0037315
UMLS CUI [2,1]
C0428175
UMLS CUI [2,2]
C0162701
subjects who perform alternating shift or night work
Description

Shift worker | Night work

Type de données

boolean

Alias
UMLS CUI [1]
C0425104
UMLS CUI [2]
C1659095
subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to screening
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
Retour au début de la page

Similar models

Eligibility Hypertension NCT00330369

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subjects who are competent to provide written consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
aged 35 to 80 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus | Chronic Kidney Diseases | Systolic Pressure mean
Item
subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmhg
boolean
C0011849 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Study Subject Systolic Pressure mean
Item
all other subjects must have a mean systolic blood pressure ≥140 mmhg
boolean
C0681850 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
Antihypertensive Agents Class Different Quantity | Diuretic
Item
receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
boolean
C0003364 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C1705242 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0012798 (UMLS CUI [2])
Gender Childbearing Potential Absent | Postmenopausal state | Female Sterilization
Item
female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Sitting systolic blood pressure Average | Sitting diastolic blood pressure Average
Item
average sitting systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg
boolean
C1319893 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
serum alt or ast >2 x the upper limit of the normal range (uln)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Tachyarrhythmia Atrial Recurrent | Recurrent ventricular tachycardia | BRADYCARDIA SYMPTOMATIC
Item
subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (cva) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C0264906 (UMLS CUI [5])
C0151517 (UMLS CUI [6])
C0004238 (UMLS CUI [7])
C0080203 (UMLS CUI [8,1])
C0018792 (UMLS CUI [8,2])
C2945760 (UMLS CUI [8,3])
C1737264 (UMLS CUI [9])
C0741627 (UMLS CUI [10])
pacemaker implant | Implantable defibrillator
Item
implanted pacemakers or implanted cardioverter defibrillator (icd)
boolean
C0848753 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
Symptomatic congestive heart failure Treatment required for
Item
symptomatic congestive heart failure requiring treatment
boolean
C0742758 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Heart valve disease Hemodynamic Significant
Item
hemodynamically significant valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
type i diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Hemodialysis | Peritoneal Dialysis | Kidney Transplantation
Item
hemodialysis or peritoneal dialysis; or history of renal transplant
boolean
C0019004 (UMLS CUI [1])
C0031139 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
Malignant Neoplasm | Recurrent tumor
Item
diagnosis or recurrence of malignancy within the past 3 years
boolean
C0006826 (UMLS CUI [1])
C0521158 (UMLS CUI [2])
Sleep Apnea | Arterial oxygen saturation measurement Sleep study
Item
sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%
boolean
C0037315 (UMLS CUI [1])
C0428175 (UMLS CUI [2,1])
C0162701 (UMLS CUI [2,2])
Shift worker | Night work
Item
subjects who perform alternating shift or night work
boolean
C0425104 (UMLS CUI [1])
C1659095 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial