ID

22261

Descrizione

Effects of Lumiracoxib and Ibuprofen on Blood Pressure and Urinary Eicosanoid Excretion in Osteoarthritis Patients With Controlled Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00419796

collegamento

https://clinicaltrials.gov/show/NCT00419796

Keywords

versioni (1)
  1. 27-05-17 27-05-17 -
Caricato su

27 mei 2017

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Osteoarthritis With Controlled Hypertension NCT00419796

Inglese

Eligibility Osteoarthritis With Controlled Hypertension NCT00419796

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female outpatients of at least 50 years of age.
Descrizione

Outpatients | Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or intra-uterine device. oral contraceptives use is not allowed 4 weeks prior screening and throughout the duration of the study. patients on hormonal replacement therapy are allowed if they have been on a stable dose for at least 6 months.
Descrizione

Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Contraception, Barrier | Vaginal Spermicides | Intrauterine Devices | Oral contraception | Hormone replacement therapy Dosage Stable

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0087145
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0029151
UMLS CUI [8,1]
C0282402
UMLS CUI [8,2]
C0178602
UMLS CUI [8,3]
C0205360
primary osteoarthritis of the hand, hip or knee according to american college of rheumatology (acr) criteria or osteoarthritis of the spine. one joint will be identified as the target joint and will be evaluated throughout the duration of the trial.
Descrizione

Primary osteoarthritis of hand | Primary osteoarthritis of hip | Primary osteoarthritis of knee | Osteoarthritis, Spine | Target Joint Identification

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2893978
UMLS CUI [2]
C2893909
UMLS CUI [3]
C2893931
UMLS CUI [4]
C2350242
UMLS CUI [5,1]
C1521840
UMLS CUI [5,2]
C0022417
UMLS CUI [5,3]
C0205396
is expected to need non-steroidal anti-inflammatory drugs (nsaid) or simple analgesic therapy for osteoarthritis for at least the next 6 weeks.
Descrizione

Anti-Inflammatory Agents, Non-Steroidal | Analgesic therapy Degenerative polyarthritis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2,1]
C0412784
UMLS CUI [2,2]
C0029408
controlled hypertension with mean sitting systolic blood pressure (mssbp) <140 mmhg and mean sitting diastolic blood pressure (msdbp) <90 mmhg (mean of 3 cuff blood pressure measurements). patients must have taken the same fixed dose of antihypertensive medication(s) on a regular basis for at least 3 consecutive months prior to screening and are not expected to adjust their antihypertensive medication(s) during the study. regular wake-up times which are expected to continue for the duration of the trial.
Descrizione

hypertension controlled | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Blood pressure cuff Measurement Quantity | Antihypertensive Agents Dosage

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0745117
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
UMLS CUI [4,1]
C0180208
UMLS CUI [4,2]
C0242485
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0003364
UMLS CUI [5,2]
C0178602
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
Descrizione

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C2348205
patients who have any known allergic-type reactions after taking acetylsalicylic acid or nsaids which may include (but are not limited to) history of asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reactions
Descrizione

Allergic Reaction Aspirin | Allergic Reaction Non-Steroidal Anti-Inflammatory Agents | Asthma | Rhinitis | Nasal Polyps | Angioedema | Urticaria | Allergic Reaction

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0003211
UMLS CUI [3]
C0004096
UMLS CUI [4]
C0035455
UMLS CUI [5]
C0027430
UMLS CUI [6]
C0002994
UMLS CUI [7]
C0042109
UMLS CUI [8]
C1527304
history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
Descrizione

Malignant Neoplasms Organ system Treated | Malignant Neoplasms Organ system Untreated | Neoplasm Recurrence, Local | Neoplasm Metastasis | Basal cell carcinoma Localized

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0460002
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0460002
UMLS CUI [2,3]
C0332155
UMLS CUI [3]
C0027643
UMLS CUI [4]
C0027627
UMLS CUI [5,1]
C0007117
UMLS CUI [5,2]
C0392752
pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (> 5 miu/ml).
Descrizione

Pregnancy HCG pregnancy test Positive | Conception | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0546577
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C0009637
UMLS CUI [3]
C0006147
history of cardiac and cerebral thrombotic/ ischemic diseases and/ or events as listed below:
Descrizione

Heart Diseases | Cerebral disorder | Thrombosis | Myocardial Ischemia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0234387
UMLS CUI [3]
C0040053
UMLS CUI [4]
C0151744
angina pectoris (of any severity) or other evidence of coronary heart disease; myocardial infarction; coronary heart disease with ecg-evidence of silent myocardial infarction; coronary artery bypass grafting (cabg) or percutaneous coronary intervention (any pci procedure); clinically significant carotid artery stenosis or history of carotid endarterectomy; congestive heart failure, nyha class ii - iv; second or third degree heart block in the absence of permanent pacing and all potentially life-threatening arrhythmia or symptomatic arrhythmia; clinically significant valvular heart disease; cerebrovascular disease; peripheral arterial disease
Descrizione

Angina Pectoris Severity | Coronary heart disease | Myocardial Infarction | Silent Myocardial Infarction by ECG Finding | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Carotid Stenosis | Carotid Endarterectomy | Congestive heart failure New York Heart Association Classification | Second degree atrioventricular block | Complete atrioventricular block | Cardiac pacing Permanent Absent | Cardiac Arrhythmia Life Threatening Absent | Cardiac Arrhythmia Symptomatic Absent | Heart valve disease | Cerebrovascular Disorders | Peripheral Vascular Diseases

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0439793
UMLS CUI [2]
C0010068
UMLS CUI [3]
C0027051
UMLS CUI [4]
C3640147
UMLS CUI [5]
C0010055
UMLS CUI [6]
C1532338
UMLS CUI [7]
C0007282
UMLS CUI [8]
C0014099
UMLS CUI [9,1]
C0018802
UMLS CUI [9,2]
C1275491
UMLS CUI [10]
C0264906
UMLS CUI [11]
C0151517
UMLS CUI [12,1]
C0199640
UMLS CUI [12,2]
C0205355
UMLS CUI [12,3]
C0332197
UMLS CUI [13,1]
C0003811
UMLS CUI [13,2]
C2826244
UMLS CUI [13,3]
C0332197
UMLS CUI [14,1]
C0003811
UMLS CUI [14,2]
C0231220
UMLS CUI [14,3]
C0332197
UMLS CUI [15]
C0018824
UMLS CUI [16]
C0007820
UMLS CUI [17]
C0085096
other protocol-defined inclusion/exclusion criteria may apply
Descrizione

Clinical Trial Eligibility Criteria Study Protocol

Tipo di dati

boolean

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

Eligibility Osteoarthritis With Controlled Hypertension NCT00419796

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male and female outpatients of at least 50 years of age.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Contraception, Barrier | Vaginal Spermicides | Intrauterine Devices | Oral contraception | Hormone replacement therapy Dosage Stable
Item
female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or intra-uterine device. oral contraceptives use is not allowed 4 weeks prior screening and throughout the duration of the study. patients on hormonal replacement therapy are allowed if they have been on a stable dose for at least 6 months.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0004764 (UMLS CUI [4])
C0087145 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0029151 (UMLS CUI [7])
C0282402 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0205360 (UMLS CUI [8,3])
Primary osteoarthritis of hand | Primary osteoarthritis of hip | Primary osteoarthritis of knee | Osteoarthritis, Spine | Target Joint Identification
Item
primary osteoarthritis of the hand, hip or knee according to american college of rheumatology (acr) criteria or osteoarthritis of the spine. one joint will be identified as the target joint and will be evaluated throughout the duration of the trial.
boolean
C2893978 (UMLS CUI [1])
C2893909 (UMLS CUI [2])
C2893931 (UMLS CUI [3])
C2350242 (UMLS CUI [4])
C1521840 (UMLS CUI [5,1])
C0022417 (UMLS CUI [5,2])
C0205396 (UMLS CUI [5,3])
Anti-Inflammatory Agents, Non-Steroidal | Analgesic therapy Degenerative polyarthritis
Item
is expected to need non-steroidal anti-inflammatory drugs (nsaid) or simple analgesic therapy for osteoarthritis for at least the next 6 weeks.
boolean
C0003211 (UMLS CUI [1])
C0412784 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
hypertension controlled | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Blood pressure cuff Measurement Quantity | Antihypertensive Agents Dosage
Item
controlled hypertension with mean sitting systolic blood pressure (mssbp) <140 mmhg and mean sitting diastolic blood pressure (msdbp) <90 mmhg (mean of 3 cuff blood pressure measurements). patients must have taken the same fixed dose of antihypertensive medication(s) on a regular basis for at least 3 consecutive months prior to screening and are not expected to adjust their antihypertensive medication(s) during the study. regular wake-up times which are expected to continue for the duration of the trial.
boolean
C0745117 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0180208 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0003364 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar
Item
history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
Allergic Reaction Aspirin | Allergic Reaction Non-Steroidal Anti-Inflammatory Agents | Asthma | Rhinitis | Nasal Polyps | Angioedema | Urticaria | Allergic Reaction
Item
patients who have any known allergic-type reactions after taking acetylsalicylic acid or nsaids which may include (but are not limited to) history of asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reactions
boolean
C1527304 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0004096 (UMLS CUI [3])
C0035455 (UMLS CUI [4])
C0027430 (UMLS CUI [5])
C0002994 (UMLS CUI [6])
C0042109 (UMLS CUI [7])
C1527304 (UMLS CUI [8])
Malignant Neoplasms Organ system Treated | Malignant Neoplasms Organ system Untreated | Neoplasm Recurrence, Local | Neoplasm Metastasis | Basal cell carcinoma Localized
Item
history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0460002 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0027643 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
C0007117 (UMLS CUI [5,1])
C0392752 (UMLS CUI [5,2])
Pregnancy HCG pregnancy test Positive | Conception | Breast Feeding
Item
pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (> 5 miu/ml).
boolean
C0032961 (UMLS CUI [1,1])
C0546577 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0009637 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Heart Diseases | Cerebral disorder | Thrombosis | Myocardial Ischemia
Item
history of cardiac and cerebral thrombotic/ ischemic diseases and/ or events as listed below:
boolean
C0018799 (UMLS CUI [1])
C0234387 (UMLS CUI [2])
C0040053 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
Angina Pectoris Severity | Coronary heart disease | Myocardial Infarction | Silent Myocardial Infarction by ECG Finding | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Carotid Stenosis | Carotid Endarterectomy | Congestive heart failure New York Heart Association Classification | Second degree atrioventricular block | Complete atrioventricular block | Cardiac pacing Permanent Absent | Cardiac Arrhythmia Life Threatening Absent | Cardiac Arrhythmia Symptomatic Absent | Heart valve disease | Cerebrovascular Disorders | Peripheral Vascular Diseases
Item
angina pectoris (of any severity) or other evidence of coronary heart disease; myocardial infarction; coronary heart disease with ecg-evidence of silent myocardial infarction; coronary artery bypass grafting (cabg) or percutaneous coronary intervention (any pci procedure); clinically significant carotid artery stenosis or history of carotid endarterectomy; congestive heart failure, nyha class ii - iv; second or third degree heart block in the absence of permanent pacing and all potentially life-threatening arrhythmia or symptomatic arrhythmia; clinically significant valvular heart disease; cerebrovascular disease; peripheral arterial disease
boolean
C0002962 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0010068 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C3640147 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C1532338 (UMLS CUI [6])
C0007282 (UMLS CUI [7])
C0014099 (UMLS CUI [8])
C0018802 (UMLS CUI [9,1])
C1275491 (UMLS CUI [9,2])
C0264906 (UMLS CUI [10])
C0151517 (UMLS CUI [11])
C0199640 (UMLS CUI [12,1])
C0205355 (UMLS CUI [12,2])
C0332197 (UMLS CUI [12,3])
C0003811 (UMLS CUI [13,1])
C2826244 (UMLS CUI [13,2])
C0332197 (UMLS CUI [13,3])
C0003811 (UMLS CUI [14,1])
C0231220 (UMLS CUI [14,2])
C0332197 (UMLS CUI [14,3])
C0018824 (UMLS CUI [15])
C0007820 (UMLS CUI [16])
C0085096 (UMLS CUI [17])
Clinical Trial 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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