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This study will investigate the effect on ambulatory blood pressure of lumiracoxib 100 mg once daily versus ibuprofen 600 mg three times a day in osteoarthritis patients with controlled hypertension.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumiracoxib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the 24-hour systolic BP profile of lumiracoxib 100 mg o.d. in comparison to ibuprofen 600 mg t.i.d. after 4 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the effect of lumiracoxib 100 mg o.d. on diastolic BP derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d. | ||
| Assessment of the effect of lumiracoxib 100 mg o.d. on daytime and nighttime BP (systolic and diastolic) derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d. |
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Inclusion Criteria:
Exclusion criteria
• Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Bradkey Sakran, MD | Southern Illinois Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Illinois Clinical Research | O'Fallon | Illinois | 62269 | United States | ||
| Novartis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18622250 | Result | MacDonald TM, Reginster JY, Littlejohn TW, Richard D, Lheritier K, Krammer G, Rebuli R. Effect on blood pressure of lumiracoxib versus ibuprofen in patients with osteoarthritis and controlled hypertension: a randomized trial. J Hypertens. 2008 Aug;26(8):1695-702. doi: 10.1097/HJH.0b013e328302c9fe. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C473384 | lumiracoxib |
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| Assessment of the effect of lumiracoxib 100 mg o.d. on the incidence of significant increases in ABP in comparison to ibuprofen 600 mg t.i.d. |
| Exploratory analysis of the effect of lumiracoxib 100 mg o.d. on the incidence of uncontrolled hypertension in comparison to ibuprofen 600 mg t.i.d. |
| Exploratory analysis of the effect of lumiracoxib 100 mg o.d. on the ABPM profile between 0 and 4 hours after morning dose in comparison to ibuprofen 600 mg t.i.d. |
| Nuremberg |
| Germany |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |