Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00267176
First received: December 16, 2005
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Controlled Hypertension |
Drug: lumiracoxib |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A 4-week, Multicentre, Randomized, Double-blind, Double-dummy, Parallel Group Ambulatory Blood Pressure Monitoring Study to Investigate Whether Treatment With Lumiracoxib 100 mg Once Daily Results in an Improved 24-hour Blood Pressure Profile Compared to Ibuprofen 600 mg Three Times a Day in Osteoarthritis Patients With Controlled Hypertension |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
- 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.
| Estimated Enrollment: | 1020 |
| Study Start Date: | November 2005 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Osteoarthritis of the hand, hip, knee or spine
- High blood pressure (<140/ 90 mmHg) which is controlled by antihypertensive medication(s).
Exclusion criteria
• Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267176
Locations
| United States, Illinois | |
| Southern Illinois Clinical Research | |
| O'Fallon, Illinois, United States, 62269 | |
| Germany | |
| Novartis | |
| Nuernberg, Germany | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | Bradkey Sakran, MD | Southern Illinois Clinical Research |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00267176 History of Changes |
| Other Study ID Numbers: | CCOX189A2428 |
| Study First Received: | December 16, 2005 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Austria: Federal Ministry for Health and Women Belgium: Directorate general for the protection of Public health: Medicines Brazil: National Health Surveillance Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Osteoarthritis, hypertension, lumiracoxib, ibuprofen, 24-hour blood pressure profile |
Additional relevant MeSH terms:
|
Hypertension Osteoarthritis Vascular Diseases Cardiovascular Diseases Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Lumiracoxib Diclofenac Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013