In the study the 24-hour blood pressure profile of HCT 3012 and naproxen, a commonly used anti-inflammatory drug, will be compared.
The anti-inflammatory agents currently used in the treatment of osteoarthritis are known to raise blood pressure and interfere with the treatment of hypertension.
This study is expected to enroll approximately 120 volunteer subjects with high blood pressure at 15 clinical centers in the US. The first subject has been enrolled and results are expected in the fourth quarter of 2006.
“Cardiovascular safety concerns have become a determining factor in influencing the prescription of anti-inflammatory agents and we believe that HCT 3012 will be a great commercial success if we demonstrate that it does not raise blood pressure. The trial announced today is expected to provide very important data, which together with that from our ongoing phase III efficacy study, should allow us to gain a clearer picture of the ability of nitric oxide donation to counteract the increased blood pressure observed with existing treatments for osteoarthritis,” commented Michele Garufi, chairman and CEO of NicOx.
HCT 3012 is a novel, proprietary, nitric oxide-donating derivative of naproxen.