ID

31260

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00662610

Nyckelord

Versioner (1)
  1. 2018-08-04 2018-08-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00662610

Engelsk

Eligibility Osteoarthritis NCT00662610

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age | Osteoarthritis of hip | Osteoarthritis, Knee

Datatyp

boolean

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

Hypertensive disease | Essential Hypertension Treated | Essential Hypertension Controlled

Datatyp

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).
Beskrivning

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

Datatyp

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.
Beskrivning

NSAIDs chronic | Acetaminophen chronic

Datatyp

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.
Beskrivning

Analgesic therapy To be stopped

Datatyp

boolean

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

Exclusion Criteria

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

Antihypertensive Agents Class Quantity

Datatyp

boolean

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

Diabetic - poor control

Datatyp

boolean

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

Hepatic impairment | Renal Insufficiency

Datatyp

boolean

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

Substance Use Disorders

Datatyp

boolean

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

Gastric ulcer | Duodenal Ulcer | Gastroduodenal haemorrhage

Datatyp

boolean

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

Congestive heart failure

Datatyp

boolean

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

ECG abnormal

Datatyp

boolean

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

Anticoagulants | Anticoagulants Expected

Datatyp

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.
Beskrivning

Disease Interferes with Study Protocol | Disease At risk Patient safety

Datatyp

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.
Beskrivning

Study Subject Participation Status | Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
Tillbaka till toppen

Similar models

Eligibility Osteoarthritis NCT00662610

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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