ID

29014

Description

Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01384058

Lien

https://clinicaltrials.gov/show/NCT01384058

Mots-clés

Versions (1)
  1. 20/02/2018 20/02/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

20 février 2018

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 Diabetes Mellitus Type 2 NCT01384058

Anglais

Eligibility Diabetes Mellitus Type 2 NCT01384058

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men > 18 and ≤ 75 years
Description

Gender | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
post-menopausal women ≤ 75 years (follicle stimulating hormone (fsh) >30 miu/ml, women > 60 years fsh > 20 miu/ml )
Description

Gender | Age | Postmenopausal state | Follicle stimulating hormone measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0202022
well controlled diabetes mellitus type ii (glycohaemoglobin ≤ 8,0 %)
Description

Non-Insulin-Dependent Diabetes Mellitus Well controlled | Glucohemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C3853142
UMLS CUI [2]
C0202054
ldl-cholesterol ≤ 160 mg/dl
Description

Serum LDL cholesterol measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0428474
ldl-subfractions: concentration of apob-100 in dldl (ldl-5 und ldl-6) > 25 mg/dl
Description

Low density lipoprotein subfraction | Apolipoprotein B-100 | serum LDL cholesterol direct assay | LDL 5 | LDL 6

Type de données

boolean

Alias
UMLS CUI [1]
C0578543
UMLS CUI [2]
C0205666
UMLS CUI [3]
C2210338
UMLS CUI [4]
C3167220
UMLS CUI [5]
C1954747
written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in a clinical trial within the last 30 d before screening- visit
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
patient is unable to give written informed consent
Description

Informed Consent Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
body mass index <15 kg/m² and > 35 kg/m²
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
Description

Atherosclerosis | Coronary heart disease | Peripheral Arterial Diseases | Carotid Artery Diseases

Type de données

boolean

Alias
UMLS CUI [1]
C0004153
UMLS CUI [2]
C0010068
UMLS CUI [3]
C1704436
UMLS CUI [4]
C0007273
malignoma
Description

Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
uncontrolled arterial hypertension (>160/>100 mmhg)
Description

Uncontrolled hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
clinically relevant disease of liver and/or kidneys
Description

Liver diseases | Kidney Diseases

Type de données

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
clinically relevant endocrinally or hematologic problems
Description

Endocrine System Diseases | Hematological Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C0018939
allergy to study medication (ezetimibe and/or simvastatin)
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Ezetimibe | Simvastatin allergy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1142985
UMLS CUI [3]
C0571874
alcohol- or drug abuse
Description

Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin > 3 x uln, creatine kinase > 5 x uln
Description

Laboratory Results | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin | Serum creatinine raised

Type de données

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0741494
UMLS CUI [5]
C0700225
concurrent treatment with potent cyp3a4-inhibitors (e.g. itraconazole, ketoconazole, hiv-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone)
Description

CYP3A4 Inhibitors | Itraconazole | Ketoconazole | HIV Protease Inhibitors | Erythromycin | Clarithromycin | telithromycin | nefazodone

Type de données

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C0064113
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0162714
UMLS CUI [5]
C0014806
UMLS CUI [6]
C0055856
UMLS CUI [7]
C0907410
UMLS CUI [8]
C0068485
other relevant diseases
Description

Disease Relevant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2347946
Retour au début de la page

Similar models

Eligibility Diabetes Mellitus Type 2 NCT01384058

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men > 18 and ≤ 75 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Age | Postmenopausal state | Follicle stimulating hormone measurement
Item
post-menopausal women ≤ 75 years (follicle stimulating hormone (fsh) >30 miu/ml, women > 60 years fsh > 20 miu/ml )
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0202022 (UMLS CUI [4])
Non-Insulin-Dependent Diabetes Mellitus Well controlled | Glucohemoglobin measurement
Item
well controlled diabetes mellitus type ii (glycohaemoglobin ≤ 8,0 %)
boolean
C0011860 (UMLS CUI [1,1])
C3853142 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
Serum LDL cholesterol measurement
Item
ldl-cholesterol ≤ 160 mg/dl
boolean
C0428474 (UMLS CUI [1])
Low density lipoprotein subfraction | Apolipoprotein B-100 | serum LDL cholesterol direct assay | LDL 5 | LDL 6
Item
ldl-subfractions: concentration of apob-100 in dldl (ldl-5 und ldl-6) > 25 mg/dl
boolean
C0578543 (UMLS CUI [1])
C0205666 (UMLS CUI [2])
C2210338 (UMLS CUI [3])
C3167220 (UMLS CUI [4])
C1954747 (UMLS CUI [5])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
participation in a clinical trial within the last 30 d before screening- visit
boolean
C2348568 (UMLS CUI [1])
Informed Consent Unable
Item
patient is unable to give written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Body mass index
Item
body mass index <15 kg/m² and > 35 kg/m²
boolean
C1305855 (UMLS CUI [1])
Atherosclerosis | Coronary heart disease | Peripheral Arterial Diseases | Carotid Artery Diseases
Item
clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
boolean
C0004153 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C1704436 (UMLS CUI [3])
C0007273 (UMLS CUI [4])
Malignant Neoplasms
Item
malignoma
boolean
C0006826 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled arterial hypertension (>160/>100 mmhg)
boolean
C1868885 (UMLS CUI [1])
Liver diseases | Kidney Diseases
Item
clinically relevant disease of liver and/or kidneys
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Endocrine System Diseases | Hematological Disease
Item
clinically relevant endocrinally or hematologic problems
boolean
C0014130 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Ezetimibe | Simvastatin allergy
Item
allergy to study medication (ezetimibe and/or simvastatin)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1142985 (UMLS CUI [2,2])
C0571874 (UMLS CUI [3])
Substance Use Disorders
Item
alcohol- or drug abuse
boolean
C0038586 (UMLS CUI [1])
Laboratory Results | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin | Serum creatinine raised
Item
laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin > 3 x uln, creatine kinase > 5 x uln
boolean
C1254595 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
CYP3A4 Inhibitors | Itraconazole | Ketoconazole | HIV Protease Inhibitors | Erythromycin | Clarithromycin | telithromycin | nefazodone
Item
concurrent treatment with potent cyp3a4-inhibitors (e.g. itraconazole, ketoconazole, hiv-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone)
boolean
C3850053 (UMLS CUI [1])
C0064113 (UMLS CUI [2])
C0022625 (UMLS CUI [3])
C0162714 (UMLS CUI [4])
C0014806 (UMLS CUI [5])
C0055856 (UMLS CUI [6])
C0907410 (UMLS CUI [7])
C0068485 (UMLS CUI [8])
Disease Relevant
Item
other relevant diseases
boolean
C0012634 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
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