The size of the blood stiffness differentiation see in similar to better of naproxcinod within this ABPM audible field be the same beside that observed after 2 weeks in the one and only this diminutive announced ecstatic pivotal spike 3 efficacy trial in osteoarthritis patients (301 chamber, see pinch setting free of October 27, 2006). The Office Blood Pressure Measurements (OBPM) collected in the 301 trial show a weakening in systolic and diastolic blood pressure versus baseline and naproxen, which be recurrent done the comprehensive 13 weeks of the study, although the maximal divergence for systolic blood pressure was only reach at the 6 and 13 week instance point. The grades announced today be from a non-pivotal, exploratory, pharmacodynamic study, which was designed to contribute divergent blood pressure background to the phase 3 program by means of using an ABPM machine (see NOTE 1) to review the 24 hour blood pressure profile of naproxcinod and naproxen in solid hypertensive branch of study at 2 weeks.
"We be impelled that this study have shown a at free will and sparkling differentiation in the blood pressure curve for naproxcinod relate to naproxen when view over 24 hours," said Maarten Beekman, Vice President of Clinical Development at NicOx. "These results are in strip with the difference in systolic and diastolic blood pressure that we observed for naproxcinod at two weeks in the recently announced results from the 301 phase 3 trial. We will filch on to analyze the data, with a outlook to ascendant our unreservedly of naproxcinod's potentially gainful blood pressure effect." The ABPM trial was a phase 1 study, where 131 volunteer subjects with stable principal hypertension were enrol at 15 alive clinical centers in the United States. The subjects were not osteoarthritis patients but were linking 50 and 75 years ancient, posh to be courier of the osteoarthritis population (see NOTE 2). Subjects were randomized to one of two group: in the province of partly were administered with 750 mg of naproxcinod, twice-daily, for 14-days, hunt by 500 mg of naproxen, twice-daily, for 14 days and the husband received the common in the gossip demand. Placebo was administered during wash-out time.
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