This is a phase IV clinical study which is double blind, randomized, and conducted in multiple international countries throughout Europe including Russia. The purpose of this clinical study is to demonstrate the efficacy of the study drug in patients with coronary artery disease who experience angina characterized by limited exercise capacity on a treadmill. The Sponsor selected OCT to run this clinical study, and the country that they selected that best fit this phase IV clinical study is Russia. Based on the thorough feasibility results, OCT is preparing for performing site selection visits in Russia. The total number of patients that will be recruited for this clinical study is 150 both male and female.
OCT has had significant experience in phase IV clinical studies before, knowing this the Sponsor is fully confident that OCT will be able to sufficiently supply the required patients for this clinical study. This is not the first time OCT has done business with this current Sponsor, and if everything goes according to plan there is no reason that they will not be coming back in the future to conduct other clinical trials. OCT strives to be the best CRO in CEE, CIS, and Russia so when a Sponsor brings his business back to OCT that says a lot about the quality of work being put out by OCT.
Cardiovascular diseases are the leading cause of death around the world, more people die annually from cardiovascular diseases than any other reason. According to the World Health Organization there are over 17 million people every year who perish from different cardiovascular diseases. Some of the different diseases include coronary heart disease, congenital heart disease, rheumatic heart disease, cerebrovascular disease, deep vein thrombosis and pulmonary embolism, and coronary artery disease. Out of all of these various cardiovascular diseases the one that claims the most lives on an annual basis is coronary artery disease also known as ischemic heart disease. From the more than 17 million deaths which occur annually more than 40% can be attributed solely to coronary artery disease, which makes it the most deadly cardiovascular disease. There is a process where the arteries start to narrow due to plaque caused by cholesterol built up; this is referred to as atherosclerosis.