ID

21071

Descrição

An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00403481

Link

https://clinicaltrials.gov/show/NCT00403481

Palavras-chave

Versões (2)
  1. 07/04/2017 07/04/2017 -
  2. 08/04/2017 08/04/2017 -
Transferido a

7 de abril de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Hypertension NCT00403481

Inglês

Eligibility Hypertension NCT00403481

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with type ii diabetes that are on stable treatment with hypoglycemic agents
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Stable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0020616
UMLS CUI [2,2]
C0205360
patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 140 mmhg but <200 mmhg and a msdbp less than or equal to 114 mmhg following a 3 to 4-week single-blind placebo run-in period
Descrição

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Run-in Period Placebo Single-Blind

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C3274438
UMLS CUI [3,2]
C1696465
UMLS CUI [3,3]
C0037181
the difference in mssbp between visits 3 and 4 or between visits 4 and 4x must be less than or equal to 10 mmhg
Descrição

Sitting systolic blood pressure mean Timepoint Difference

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C2348792
UMLS CUI [1,4]
C1705242
patients with a mean daytime (8am - 4pm) sbp > 130 mmhg and less than or equal to 199 mmhg and a mean daytime dbp less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (abpm) following placebo run-in period
Descrição

Systolic Pressure mean Daytime | Diastolic blood pressure mean Daytime | Blood Pressure Monitoring, Ambulatory | Run-in Period Placebo

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C0332169
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C0332169
UMLS CUI [3]
C0242876
UMLS CUI [4,1]
C3274438
UMLS CUI [4,2]
C1696465
if female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study
Descrição

Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy | Tubal Ligation | Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0520483
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of stroke or transient ischemic attack (tia) within the last one year
Descrição

Cerebrovascular accident | Transient Ischemic Attack

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
Descrição

Myocardial Infarction | Coronary revascularisation Transluminal Percutaneous | Coronary Artery Bypass Surgery | Angina, Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0877341
UMLS CUI [2,2]
C0522520
UMLS CUI [2,3]
C0522523
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0002965
presence of overt proteinuria at screening
Descrição

Proteinuria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033687
severe hypertension (dbp greater than or equal to 115 mmhg or sbp greater than or equal to 200 mmhg)
Descrição

Hypertension, severe | Diastolic blood pressure | Systolic Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0871470
patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or cushing's syndrome
Descrição

Secondary hypertension Etiology Any | Kidney Diseases | Pheochromocytoma | Cushing Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0031511
UMLS CUI [4]
C0010481
type i or type ii diabetes requiring insulin
Descrição

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021641
evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease
Descrição

Bradycardia Resting Symptomatic | Congestive heart failure | Heart valve disease Hemodynamic Significant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3278174
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C0018824
UMLS CUI [3,2]
C0019010
UMLS CUI [3,3]
C0750502
presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, atrial fibrillation, or atrial flutter
Descrição

Heart Block | First degree sinoatrial block | Wolff-Parkinson-White Syndrome | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018794
UMLS CUI [2]
C3854673
UMLS CUI [3]
C0043202
UMLS CUI [4]
C0037052
UMLS CUI [5]
C0004238
UMLS CUI [6]
C0004239
Voltar ao início da página

Similar models

Eligibility Hypertension NCT00403481

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Stable
Item
patients diagnosed with type ii diabetes that are on stable treatment with hypoglycemic agents
boolean
C0011860 (UMLS CUI [1])
C0020616 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Run-in Period Placebo Single-Blind
Item
patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 140 mmhg but <200 mmhg and a msdbp less than or equal to 114 mmhg following a 3 to 4-week single-blind placebo run-in period
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C3274438 (UMLS CUI [3,1])
C1696465 (UMLS CUI [3,2])
C0037181 (UMLS CUI [3,3])
Sitting systolic blood pressure mean Timepoint Difference
Item
the difference in mssbp between visits 3 and 4 or between visits 4 and 4x must be less than or equal to 10 mmhg
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
C1705242 (UMLS CUI [1,4])
Systolic Pressure mean Daytime | Diastolic blood pressure mean Daytime | Blood Pressure Monitoring, Ambulatory | Run-in Period Placebo
Item
patients with a mean daytime (8am - 4pm) sbp > 130 mmhg and less than or equal to 199 mmhg and a mean daytime dbp less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (abpm) following placebo run-in period
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
C0428883 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0332169 (UMLS CUI [2,3])
C0242876 (UMLS CUI [3])
C3274438 (UMLS CUI [4,1])
C1696465 (UMLS CUI [4,2])
Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy | Tubal Ligation | Childbearing Potential Contraceptive methods
Item
if female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study
boolean
C0079399 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0520483 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Transient Ischemic Attack
Item
history of stroke or transient ischemic attack (tia) within the last one year
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Myocardial Infarction | Coronary revascularisation Transluminal Percutaneous | Coronary Artery Bypass Surgery | Angina, Unstable
Item
history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
boolean
C0027051 (UMLS CUI [1])
C0877341 (UMLS CUI [2,1])
C0522520 (UMLS CUI [2,2])
C0522523 (UMLS CUI [2,3])
C0010055 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
Proteinuria
Item
presence of overt proteinuria at screening
boolean
C0033687 (UMLS CUI [1])
Hypertension, severe | Diastolic blood pressure | Systolic Pressure
Item
severe hypertension (dbp greater than or equal to 115 mmhg or sbp greater than or equal to 200 mmhg)
boolean
C4013784 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
Secondary hypertension Etiology Any | Kidney Diseases | Pheochromocytoma | Cushing Syndrome
Item
patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or cushing's syndrome
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2])
C0031511 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin
Item
type i or type ii diabetes requiring insulin
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Bradycardia Resting Symptomatic | Congestive heart failure | Heart valve disease Hemodynamic Significant
Item
evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease
boolean
C3278174 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0018824 (UMLS CUI [3,1])
C0019010 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
Heart Block | First degree sinoatrial block | Wolff-Parkinson-White Syndrome | Sick Sinus Syndrome | Atrial Fibrillation | Atrial Flutter
Item
presence of heart block greater than first degree sinoatrial block, wolff-parkinson-white syndrome, sick sinus syndrome, atrial fibrillation, or atrial flutter
boolean
C0018794 (UMLS CUI [1])
C3854673 (UMLS CUI [2])
C0043202 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0004239 (UMLS CUI [6])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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