Both doses of naproxcinod showed a similar blood pressure profile to placebo, as indicated by one-sided 95% confidence intervals (CIs). Naproxen 500 mg bid raised systolic blood pressure (SBP) by 2.0 mmHg compared to placebo, in terms of the mean change between baseline and the average over weeks 2, 6 and 13. Further analyses on these pooled data are ongoing and NicOx plans to disclose more detailed results at leading medical conferences and in peer reviewed scientific publications during 2009 and 2010.
Two additional ABPM studies provided critical, complementary data to the phase 3 program
In November and December, NicOx announced the top-line results of the 111 and 112 clinical pharmacology studies in OA patients with controlled hypertension. These trials were designed to assess the 24-hour blood pressure profile of naproxcinod and two of the most widely used non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen and naproxen. The state of the art ABPM technique was used, providing critical, complementary data to the phase 3 OBPM data.
- In the 111 study, 118 patients were randomized to receive naproxcinod or naproxen, with escalating doses every three weeks (375, 750 and 1125 mg bid for naproxcinod, 250, 500 and 750 mg bid for naproxen). Over the whole study period, naproxcinod lowered SBP by 2.3 mmHg from baseline and naproxen raised it by 1.5 mmHg from baseline. - In the 112 study, 299 patients were randomized to receive naproxcinod 375 mg bid, naproxcinod 750 mg bid, naproxen 250 mg bid, naproxen
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