To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with osteoarthritis and controlled essential hypertension
This is a 12-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod and naproxen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to different naproxcinod or naproxen doses in a 1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
naproxcinod 375 mg -750 mg -1125 mg bid
naproxen 250 mg - 500mg -750 mg bid
Unnamed facility
Mobile, Alabama, United States
To characterize the 24-hour arterial blood pressure profile of different doses of naproxcinod, as measured by ABPM after each treatment period, compared to different doses of naproxen after three 3-week forced titration.
Time frame: 11 weeks
To evaluate the general safety and tolerability as well as the PK/PD profile of different doses of naproxcinod compared to different doses of naproxen.
Time frame: 11 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Tempe, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Buena Park, California, United States
Unnamed facility
Colorado Springs, Colorado, United States
Unnamed facility
Boynton Beach, Florida, United States
Unnamed facility
Stockbridge, Georgia, United States
Unnamed facility
Boise, Idaho, United States
Unnamed facility
Chicago, Illinois, United States
...and 19 more locations