ID

29939

Description

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

Keywords

Versions (1)
  1. 4/28/18 4/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00698646

English

Eligibility Hypertension NCT00698646

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 70 years or older.
Description

Age

Data type

boolean

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

Hypertensive disease

Data type

boolean

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

Sitting systolic blood pressure mean

Data type

boolean

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

Protocol Compliance

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Investigational New Drugs

Data type

boolean

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

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar

Data type

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.
Description

Blood pressure determination | Sitting diastolic blood pressure mean

Data type

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.
Description

Antihypertensive Agents Quantity | Sitting systolic blood pressure mean

Data type

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
Description

Exclusion Criteria Study Protocol

Data type

boolean

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

Eligibility Hypertension NCT00698646

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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