0 Ratings
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

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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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