Pfizer Inc will sponsor a major clinical study to further assess its COX-2 medication Celebrex (celecoxib) in osteoarthritis (OA) patients at high risk for cardiovascular disease.

This study is part of a larger CV exploration programme with Celebrex that started over 18 months ago. This newly announced clinical trial, which will be conducted at major universities and hospitals around the world, is expected to start early in 2005. Due to recent questions raised about the cardiovascular safety of the COX-2 specific inhibitors, Pfizer will be discussing the study design with the FDA and other regulatory agencies prior to finalizing its details and start date, the company said in a release.

Dr. Joseph Feczko, president of worldwide development at Pfizer said, "In fact, small mechanistic studies suggest that Celebrex's anti-inflammatory properties as well as additional unique Celebrex-specific characteristics may improve vascular function in patients with established coronary artery disease. That is why we feel it is important at this time to announce our plans to conduct the first large-scale clinical study involving the use of a COX-2 specific inhibitor to look at inflammation and CV events in osteoarthritis patients at high risk for cardiovascular disease."

The study will enrol more than 4,000 patients around the world who have had a recent heart attack and who also have a history of osteoarthritis. The study will assess the effects of Celebrex on inflammation and cardiovascular (CV) events. The multi-centre, randomized, placebo-controlled study will be conducted over a period of at least two years and will include rigorous monitoring of cardiovascular safety by an independent data safety monitoring committee.