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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumiracoxib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936-1080 | United States |
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| Pharmacokinetics |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C473384 | lumiracoxib |
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