ID

34669

Descrição

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

Palavras-chave

  1. 22/01/2019 22/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Systolic Hypertension NCT01281306

Eligibility Systolic Hypertension NCT01281306

Inclusion Criteria
Descrição

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.
Descrição

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

Tipo de dados

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.
Descrição

Able to communicate | Protocol Compliance | Medication Compliance Good

Tipo de dados

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension
Descrição

Hypertension, severe

Tipo de dados

boolean

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

Angioedema Drug-induced | Angioedema

Tipo de dados

boolean

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

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Childbearing Potential | Exception Use of Contraceptive methods

Tipo de dados

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.
Descrição

Secondary hypertension

Tipo de dados

boolean

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

Eligibility Criteria Study Protocol

Tipo de dados

boolean

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

Similar models

Eligibility Systolic Hypertension NCT01281306

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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