Information:
Fel:
ID
39989
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT01368536
Nyckelord
Versioner (1)
- 2020-03-08 2020-03-08 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
8 mars 2020
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hypertension NCT01368536
Eligibility Hypertension NCT01368536
- StudyEvent: Eligibility
Similar models
Eligibility Hypertension NCT01368536
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
C1518321 (UMLS CUI [1,2])
C0585941 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
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])
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])
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])
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])
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])
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])
C2348563 (UMLS CUI [1,2])