Clinical trial: Effects of Lumiracoxib and Ibuprofen on Blood Pressure and Urinary Eicosanoid Excretion in Osteoarthritis Patients With Controlled Hypertension (NCT00419796)

Eligibility criteria:
Inclusion Criteria:

          -  Male and female outpatients of at least 50 years of age.

          -  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.

          -  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.

          -  Is expected to need non-steroidal anti-inflammatory drugs (NSAID) or simple analgesic
             therapy for osteoarthritis for at least the next 6 weeks.

          -  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.

        Exclusion Criteria:

          -  History of hypersensitivity to any of the study drugs or to drugs with similar
             chemical structures.

          -  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

          -  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.

          -  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).

          -  History of cardiac and cerebral thrombotic/ ischemic diseases and/ or events as listed
             below:

        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

        Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Entailment