patients will be 40 years, or older, with osteoarthritis in at least
one hip or knee and a diagnosis of controlled essential hypertension.
Following a one week screening period, patients will be randomized to
either one of five groups, which will receive 13 weeks of treatment
with: naproxcinod 375 mg bid (twice-daily), naproxcinod 750 mg bid,
naproxen 250 mg bid, naproxen 500 mg bid or ibuprofen 600 mg tid. At
the end of the treatment period, all patients will receive placebo for
2 weeks. 24-hour blood pressure monitoring will be conducted at
baseline and at the end of the 13-week treatment period. The primary
objective of the study is to assess the mean change from baseline in
the average 24-hour systolic blood pressure, as well as evaluating the
general safety and tolerability of naproxcinod.
Staffan Stromberg, Vice President of Drug Development at NicOx, said: "We have chosen naproxen as the comparator in the pivotal phase 3 studies, due to its well established anti-inflammatory efficacy and its perception as the least risky of the existing NSAIDs in terms of blood pressure and cardiovascular safety. In the 112 study, we will also obtain long term 24-hour blood pressure comparisons between our first CINOD and ibuprofen, the most widely used NSAID."
NOTE 1: The biological mechanisms by which NSAIDs increase blood
pressure are not well understood, although an increase in blood vessel
constriction, interference with antihypertensive treatment and retaining
dietary salt all seem to contribute. The extent of the increase is not
fully defined, although there appears to be a variation between different
products, with ibuprofen and the selective COX-2 inhibitors bringing about
greater increases than non- selective drugs, such as naproxen. However, all
existing products have been associated with some bloo
|SOURCE NicOx S.A.|
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