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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00267176 |
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Date of registration:
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16/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension
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Scientific title:
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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 |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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1020 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00267176 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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United States
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Contacts
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Name:
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Bradkey Sakran, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Southern Illinois Clinical Research |
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Key inclusion & exclusion criteria
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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
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Controlled Hypertension
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Intervention(s)
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Drug: lumiracoxib
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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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.
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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.
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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.
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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.
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Secondary ID(s)
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CCOX189A2428
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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