ID

39989

Descripción

Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01368536

Link

https://clinicaltrials.gov/show/NCT01368536

Palabras clave

  1. 8/3/20 8/3/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de marzo de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Hypertension NCT01368536

Eligibility Hypertension NCT01368536

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with stage 2 hypertension within protocol limits at randomization
Descripción

Hypertensive disease Stage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0699749
patients with type 2 diabetes mellitus with hga1c less than or equal to 9%
Descripción

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
patients with newly diagnosed hypertension or patients who have not received antihypertensive therapy for at least 4 weeks prior to screening
Descripción

Hypertensive disease Newly Diagnosed | Antihypertensive therapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients taking 4 or more antihypertensive medications at screening visit
Descripción

Antihypertensive Agents Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
patients with uncontrolled bp (> 140/90 mmhg) while taking 3 or more antihypertensives at their maximum approved doses
Descripción

Blood Pressure Uncontrolled | Blood pressure determination | Antihypertensive Agents Quantity Maximum Tolerated Dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0005824
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0752079
type 2 diabetes mellitus requiring insulin treatment
Descripción

Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0557978
patients with hga1c > 9%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
patients with known gout
Descripción

Gout

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018099
known history of cancer within the past 5 years
Descripción

History of cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0455471
patients who are pregnant or nursing mothers
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who have participated in an investigational clinical trial within the 30 days prior to screening.
Descripción

Study Subject Participation Status | Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
other protocol-defined inclusion/exclusion criteria may apply
Descripción

Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Hypertension NCT01368536

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease Stage
Item
patients with stage 2 hypertension within protocol limits at randomization
boolean
C0020538 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
patients with type 2 diabetes mellitus with hga1c less than or equal to 9%
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Hypertensive disease Newly Diagnosed | Antihypertensive therapy Absent
Item
patients with newly diagnosed hypertension or patients who have not received antihypertensive therapy for at least 4 weeks prior to screening
boolean
C0020538 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0585941 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Quantity
Item
patients taking 4 or more antihypertensive medications at screening visit
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Blood Pressure Uncontrolled | Blood pressure determination | Antihypertensive Agents Quantity Maximum Tolerated Dose
Item
patients with uncontrolled bp (> 140/90 mmhg) while taking 3 or more antihypertensives at their maximum approved doses
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0005824 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0752079 (UMLS CUI [3,3])
Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin regime
Item
type 2 diabetes mellitus requiring insulin treatment
boolean
C0011860 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0557978 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
patients with hga1c > 9%
boolean
C0474680 (UMLS CUI [1])
Gout
Item
patients with known gout
boolean
C0018099 (UMLS CUI [1])
History of cancer
Item
known history of cancer within the past 5 years
boolean
C0455471 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patients who are pregnant or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial
Item
patients who have participated in an investigational clinical trial within the 30 days prior to screening.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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