ID

29939

Descrição

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.; ODM derived from: https://clinicaltrials.gov/show/NCT00698646

Link

https://clinicaltrials.gov/show/NCT00698646

Palavras-chave

  1. 28/04/2018 28/04/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

28 de abril de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Hypertension NCT00698646

Eligibility Hypertension NCT00698646

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 70 years or older.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients with hypertension prior to being randomized into study.
Descrição

Hypertensive disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020538
patients must have an office cuff mssbp ≥ 140 and ≤ 200 mmhg systolic.
Descrição

Sitting systolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
have the ability to communicate and comply with all study requirements.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
provide written informed consent to participate in the study prior to any screening or study procedures.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of other investigational drugs within 30 days of enrollment.
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
Descrição

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C2348205
office blood pressure measured by office machine cuff with a mean of (3) msdbp ≥ 120 mmhg at anytime during the screening / washout period.
Descrição

Blood pressure determination | Sitting diastolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
patients taking 3 or more antihypertensive drugs and mssbp ≥ 160 mmhg at the time of visit 1.
Descrição

Antihypertensive Agents Quantity | Sitting systolic blood pressure mean

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
other protocol-defined exclusion criteria may apply
Descrição

Exclusion Criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Hypertension NCT00698646

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 70 years or older.
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease
Item
patients with hypertension prior to being randomized into study.
boolean
C0020538 (UMLS CUI [1])
Sitting systolic blood pressure mean
Item
patients must have an office cuff mssbp ≥ 140 and ≤ 200 mmhg systolic.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Protocol Compliance
Item
have the ability to communicate and comply with all study requirements.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
provide written informed consent to participate in the study prior to any screening or study procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
use of other investigational drugs within 30 days of enrollment.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar
Item
history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
Blood pressure determination | Sitting diastolic blood pressure mean
Item
office blood pressure measured by office machine cuff with a mean of (3) msdbp ≥ 120 mmhg at anytime during the screening / washout period.
boolean
C0005824 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Antihypertensive Agents Quantity | Sitting systolic blood pressure mean
Item
patients taking 3 or more antihypertensive drugs and mssbp ≥ 160 mmhg at the time of visit 1.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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