Official Title: “A 4-Week, Multicentre, Randomized, Double-Blind, Placebo Controlled, Double Dummy, Parallel Group Study, to Assess the Effect of Lumiracoxib 100 mg o.d. and Ibuprofen 600 mg t.i.d on 24-Hour Blood Pressure Profile and on Urinary Excretions of Eicosanoids, in Osteoarthritis Patients With Controlled Hypertension”

This randomized study will compare the effect of lumiracoxib, ibuprofen and placebo on 24-hour blood pressure profile and on urinary excretions of eicosanoids in controlled hypertensive patients who have osteoarthritis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study

Primary:

• Change from baseline in average 24-hour systolic blood pressure (BP) derived from ambulatory blood pressure monitoring (ABPM) after 4 weeks of treatment
• Urinary eicosanoid excretion

Secondary:

• Change from baseline in average 24-hour diastolic BP derived from ABPM after 4 weeks of treatment
• Day and night time blood pressure (systolic and diastolic) derived from ABPM after 4 weeks of treatment
• Pharmacokinetics

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

Lead Sponsor: Novartis

Novartis

East Hanover New Jersey 07936-1080 United States

Overall Clinical Trial Officials and Contacts

Novartis Principal Investigator Investigator site  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419796

Study ID Number: CCOX189A2475

ClinicalTrials.gov Identifier: NCT00419796

Health Authority: United States: Food and Drug Administration