To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in patients with osteoarthritis and controlled essential hypertension
This is a 16-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod, naproxen, and ibuprofen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to naproxcinod 375mg, naproxcinod 750mg, naproxen 250mg, naproxen 500mg, or ibuprofen 600mg in a 1:1:1:1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
naproxcinod 375 mg bid
naproxcinod 750 mg bid
naproxen 250 mg bid
To characterize the 24-hour arterial blood pressure profile of naproxcinod, compared to naproxen as measured by ABPM, through assessing the mean change from baseline in patients with OA and controlled essential hypertension.
Time frame: 15 weeks
To characterize the 24-hour arterial blood pressure profile of naproxcinod compared to ibuprofen as measured by ABPM, through assessing the mean change from baseline in patients with osteoarthritis and controlled essential hypertension.
Time frame: 15 weeks
To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.
Time frame: 15 weeks
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naproxen 500 mg bid
ibuprofen 600 mg tid
Unnamed facility
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Sierra Vista, Arizona, United States
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Carmichael, California, United States
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Fair Oaks, California, United States
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Long Beach, California, United States
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Pico Rivera, California, United States
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Upland, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
...and 47 more locations