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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00419796 |
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.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis With Controlled Hypertension |
Drug: Lumiracoxib |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
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 |
Estimated Enrollment: | 78 |
Study Start Date: | November 2006 |
Study Completion Date: | September 2007 |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study ID Numbers: | CCOX189A2475 |
Study First Received: | January 8, 2007 |
Last Updated: | November 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00419796 |
Health Authority: | United States: Food and Drug Administration |
Osteoarthritis, controlled hypertension, lumiracoxib, ibuprofen, high blood pressure |
Prexige Ibuprofen Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Vascular Diseases Rheumatic Diseases Hypertension |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Cyclooxygenase 2 Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |