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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00419796 |
Purpose
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 |
Eligibility| 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
Contacts and Locations
More Information
| Study ID Numbers: | CCOX189A2475 |
| Study First Received: | January 8, 2007 |
| Last Updated: | November 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00419796 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Osteoarthritis, controlled hypertension, lumiracoxib, ibuprofen, high blood pressure |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Osteoarthritis Physiological Effects of Drugs Cyclooxygenase 2 Inhibitors Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics Prexige |
Ibuprofen Joint Diseases Cyclooxygenase Inhibitors Vascular Diseases Enzyme Inhibitors Rheumatic Diseases Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Hypertension |