ID

34669

Beschrijving

An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01281306

Link

https://clinicaltrials.gov/show/NCT01281306

Trefwoorden

Versies (1)
  1. 22-01-19 22-01-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 januari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Systolic Hypertension NCT01281306

Engels

Eligibility Systolic Hypertension NCT01281306

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent must be obtained before any assessment is performed. patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
Beschrijving

Informed Consent | Systolic hypertension, mild | Systolic hypertension Moderate | Did not receive therapy or drug for | Antihypertensive therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1845210
UMLS CUI [3,1]
C0221155
UMLS CUI [3,2]
C0205081
UMLS CUI [4]
C0332155
UMLS CUI [5]
C0585941
ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.
Beschrijving

Able to communicate | Protocol Compliance | Medication Compliance Good

Datatype

boolean

Alias
UMLS CUI [1]
C2364293
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C3489773
UMLS CUI [3,2]
C0205170
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension
Beschrijving

Hypertension, severe

Datatype

boolean

Alias
UMLS CUI [1]
C4013784
history of angioedema, drug-related or otherwise, as reported by the patient.
Beschrijving

Angioedema Drug-induced | Angioedema

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002994
UMLS CUI [1,2]
C0458082
UMLS CUI [2]
C0002994
pregnant or nursing (lactating) women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of child-bearing potential (wocbp), unless they are using adequate birth control methods.
Beschrijving

Childbearing Potential | Exception Use of Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0700589
history or evidence of a secondary form of hypertension.
Beschrijving

Secondary hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0155616
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

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

Eligibility Systolic Hypertension NCT01281306

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Systolic hypertension, mild | Systolic hypertension Moderate | Did not receive therapy or drug for | Antihypertensive therapy
Item
written informed consent must be obtained before any assessment is performed. patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
boolean
C0021430 (UMLS CUI [1])
C1845210 (UMLS CUI [2])
C0221155 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0332155 (UMLS CUI [4])
C0585941 (UMLS CUI [5])
Able to communicate | Protocol Compliance | Medication Compliance Good
Item
ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.
boolean
C2364293 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C3489773 (UMLS CUI [3,1])
C0205170 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe
Item
severe hypertension
boolean
C4013784 (UMLS CUI [1])
Angioedema Drug-induced | Angioedema
Item
history of angioedema, drug-related or otherwise, as reported by the patient.
boolean
C0002994 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C0002994 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential | Exception Use of Contraceptive methods
Item
women of child-bearing potential (wocbp), unless they are using adequate birth control methods.
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Secondary hypertension
Item
history or evidence of a secondary form of hypertension.
boolean
C0155616 (UMLS CUI [1])
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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