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])
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])