Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension
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
1 other identifier
interventional
1,020
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 16, 2005
CompletedFirst Posted
Study publicly available on registry
December 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedFebruary 7, 2017
February 1, 2017
10 months
December 16, 2005
February 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the hand, hip, knee or spine
- High blood pressure (\<140/ 90 mmHg) which is controlled by antihypertensive medication(s).
You may not qualify if:
- Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Southern Illinois Clinical Research
O'Fallon, Illinois, 62269, United States
Novartis
Nuremberg, Germany
Related Publications (1)
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.
PMID: 18622250RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradkey Sakran, MD
Southern Illinois Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2005
First Posted
December 20, 2005
Study Start
November 1, 2005
Primary Completion
September 1, 2006
Last Updated
February 7, 2017
Record last verified: 2017-02