ID

31261

Description

To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00662896

Link

https://clinicaltrials.gov/show/NCT00662896

Keywords

Versions (1)
  1. 8/5/18 8/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00662896

English

Eligibility Osteoarthritis NCT00662896

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age | Osteoarthritis of hip | Osteoarthritis, Knee

Data type

boolean

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

Hypertensive disease | Essential Hypertension Treated | Essential Hypertension Controlled

Data type

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 blockers (arb) or beta-blocker (bb).
Description

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

Data type

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.
Description

NSAIDs chronic | Acetaminophen chronic

Data type

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.
Description

Analgesic therapy To be stopped

Data type

boolean

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

Exclusion Criteria

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

Antihypertensive Agents Class Quantity

Data type

boolean

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

Diabetic - poor control

Data type

boolean

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

Hepatic impairment | Renal Insufficiency

Data type

boolean

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

Substance Use Disorders

Data type

boolean

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

Gastric ulcer | Duodenal Ulcer | Gastroduodenal haemorrhage

Data type

boolean

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

Congestive heart failure

Data type

boolean

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

ECG abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0522055
current or history of a medical disease that could interfere with the study objectives or put the patient's safety at risk.
Description

Disease Interferes with Study Protocol | Disease At risk Patient safety

Data type

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
current or expected use of anticoagulants.
Description

Anticoagulants | Anticoagulants Expected

Data type

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C1517001
participation within 30 days prior to pre-screening in another investigational study.
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

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

Eligibility Osteoarthritis NCT00662896

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 blockers (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])
Disease Interferes with Study Protocol | Disease At risk Patient safety
Item
current or history of a 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])
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])
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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