ID

31260

Descrição

A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure; ODM derived from: https://clinicaltrials.gov/show/NCT00662610

Link

https://clinicaltrials.gov/show/NCT00662610

Palavras-chave

Versões (1)
  1. 04/08/2018 04/08/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de agosto de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00662610

Inglês

Eligibility Osteoarthritis NCT00662610

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
men/women, 40 or older, diagnosed with hip or knee osteoarthritis.
Descrição

Age | Osteoarthritis of hip | Osteoarthritis, Knee

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0029410
UMLS CUI [3]
C0409959
hypertensive patient with treated and controlled essential hypertension.
Descrição

Hypertensive disease | Essential Hypertension Treated | Essential Hypertension Controlled

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0085580
UMLS CUI [3,2]
C2911690
must receive at least one antihypertensive treatment from the following drug classes: diuretic, angiotensin-converting enzyme (ace) inhibitor, angiotensin receptor blocker (arb) or beta-blocker (bb).
Descrição

Antihypertensive therapy Quantity | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0001645
must be current chronic user of nsaids or acetaminophen.
Descrição

NSAIDs chronic | Acetaminophen chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0000970
UMLS CUI [2,2]
C0205191
must discontinue all analgesic therapy at screening.
Descrição

Analgesic therapy To be stopped

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0412784
UMLS CUI [1,2]
C1272691
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than two different classes of antihypertensive drugs.
Descrição

Antihypertensive Agents Class Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C1265611
uncontrolled diabetes.
Descrição

Diabetic - poor control

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0421258
hepatic or renal impairment.
Descrição

Hepatic impairment | Renal Insufficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1565489
a history of alcohol/drug abuse.
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
Descrição

Gastric ulcer | Duodenal Ulcer | Gastroduodenal haemorrhage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038358
UMLS CUI [2]
C0013295
UMLS CUI [3]
C1096494
history of congestive heart failure.
Descrição

Congestive heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018802
clinically relevant abnormal ecg.
Descrição

ECG abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0522055
current or expected use of anticoagulants.
Descrição

Anticoagulants | Anticoagulants Expected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C1517001
current or history of any medical disease that could interfere with the study objectives or put the patient's safety at risk.
Descrição

Disease Interferes with Study Protocol | Disease At risk Patient safety

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
participation within 30 days prior to pre-screening in another investigational study.
Descrição

Study Subject Participation Status | Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Similar models

Eligibility Osteoarthritis NCT00662610

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Osteoarthritis of hip | Osteoarthritis, Knee
Item
men/women, 40 or older, diagnosed with hip or knee osteoarthritis.
boolean
C0001779 (UMLS CUI [1])
C0029410 (UMLS CUI [2])
C0409959 (UMLS CUI [3])
Hypertensive disease | Essential Hypertension Treated | Essential Hypertension Controlled
Item
hypertensive patient with treated and controlled essential hypertension.
boolean
C0020538 (UMLS CUI [1])
C0085580 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0085580 (UMLS CUI [3,1])
C2911690 (UMLS CUI [3,2])
Antihypertensive therapy Quantity | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists
Item
must receive at least one antihypertensive treatment from the following drug classes: diuretic, angiotensin-converting enzyme (ace) inhibitor, angiotensin receptor blocker (arb) or beta-blocker (bb).
boolean
C0585941 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0001645 (UMLS CUI [5])
NSAIDs chronic | Acetaminophen chronic
Item
must be current chronic user of nsaids or acetaminophen.
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0000970 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Analgesic therapy To be stopped
Item
must discontinue all analgesic therapy at screening.
boolean
C0412784 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Class Quantity
Item
more than two different classes of antihypertensive drugs.
boolean
C0003364 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Diabetic - poor control
Item
uncontrolled diabetes.
boolean
C0421258 (UMLS CUI [1])
Hepatic impairment | Renal Insufficiency
Item
hepatic or renal impairment.
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Substance Use Disorders
Item
a history of alcohol/drug abuse.
boolean
C0038586 (UMLS CUI [1])
Gastric ulcer | Duodenal Ulcer | Gastroduodenal haemorrhage
Item
diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
boolean
C0038358 (UMLS CUI [1])
C0013295 (UMLS CUI [2])
C1096494 (UMLS CUI [3])
Congestive heart failure
Item
history of congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
ECG abnormal
Item
clinically relevant abnormal ecg.
boolean
C0522055 (UMLS CUI [1])
Anticoagulants | Anticoagulants Expected
Item
current or expected use of anticoagulants.
boolean
C0003280 (UMLS CUI [1])
C0003280 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Disease Interferes with Study Protocol | Disease At risk Patient safety
Item
current or history of any medical disease that could interfere with the study objectives or put the patient's safety at risk.
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Study Subject Participation Status | Clinical Trial
Item
participation within 30 days prior to pre-screening in another investigational study.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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