NicOx has launched a clinical study designed to compare the 24-hour blood pressure profile of HCT 3012 and naproxen, using ambulatory blood pressure monitoring (ABPM). The study is expected to enroll approximately 120 volunteer subjects with stable essential hypertension (high blood pressure) at 15 clinical centers in the U.S. The first subject has been enrolled and results are expected in the fourth quarter of 2006.
HCT 3012 is a novel, proprietary, nitric oxide-donating derivative of naproxen, which is currently in Phase III clinical development for the treatment of the signs and symptoms of osteoarthritis. In addition to confirming the product's efficacy and overall safety in patients with osteoarthritis, the Phase III program aims to demonstrate that HCT 3012 has no detrimental effect on blood pressure and for this reason standardized, controlled, office blood pressure measurements are being made in the ongoing trial.