Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis,; Controlled Hypertension
Intervention: lumiracoxib (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Bradkey Sakran, MD, Principal Investigator, Affiliation: Southern Illinois Clinical Research
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
Novartis, Nuernberg, Germany
Southern Illinois Clinical Research, O'Fallon, Illinois 62269, United States
Additional Information
Osteoarthritis and High Blood Pressure Study
Starting date: November 2005
Last updated: December 13, 2007
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