ID

39989

Description

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

Lien

https://clinicaltrials.gov/show/NCT01368536

Mots-clés

  1. 08/03/2020 08/03/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

8 mars 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Hypertension NCT01368536

Eligibility Hypertension NCT01368536

Inclusion Criteria
Description

Inclusion Criteria

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

Hypertensive disease Stage

Type de données

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%
Description

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

Type de données

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
Description

Hypertensive disease Newly Diagnosed | Antihypertensive therapy Absent

Type de données

boolean

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

Exclusion Criteria

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

Antihypertensive Agents Quantity

Type de données

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
Description

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

Type de données

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
Description

Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin regime

Type de données

boolean

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

Hemoglobin A1c measurement

Type de données

boolean

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

Gout

Type de données

boolean

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

History of cancer

Type de données

boolean

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

Pregnancy | Breast Feeding

Type de données

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.
Description

Study Subject Participation Status | Clinical Trial

Type de données

boolean

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

Eligibility Criteria Study Protocol

Type de données

boolean

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

Similar models

Eligibility Hypertension NCT01368536

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])

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