This is a double-blind, randomized, multicenter, international, parallel group versus placebo, phase III efficacy study in patients with CAD.
For the current study, at least 100 centres in 13 Countries (Austria, Germany, Greece, Ireland, Italy, Spain, Switzerland, UK, Russia, Romania, Ukraine, Bulgaria and Albania) will be initiated. Each centre will randomize approximately 12 patients with CAD confirmed by angiography, or prior MI, or prior revascularization (PCI, CABG) and with exercise induced angina not controlled by the current therapy, with or without anginal pain, to make the total of 1216 subjects, half of which will be treated with the investigational drug, and another half – with placebo.
The primary study objective will be to verify whether the investigational drug is effective in increasing exercise capacity (exercise treadmill time). Secondary objective is to verify whether the investigational drug is effective in reducing angina frequency and nitroglycerin/nitrates consumption and to assess treatment safety.
OCT has serious experience in late phase – so called “pivotal” – studies organization and conduct, including phase III trials – more than 40 of those can be found in our proven track record. The geography of OCT offices can guarantee rapid enrollment – countries of our operation (Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia, Bulgaria, USA) cover a significant patient population of more than 250 million people, which makes it a favorable region for pivotal studies conduct.
Moreover, OCT has serious expertise in cardiology studies – 14 studies in different indications has been conducted by OCT since 2006, including 6 pivotal (phase III) clinical trials.
The major reason is the fact that Eastern Europe has always been an attractive region for cardiology studies due to the high incidence rates in this region.
According to statistics, nowadays Cardiovascular diseases account for about 60 percent of all deaths in Russia, and there is a number of reasons for that, such as high levels of alcohol consumption and smoking prevalence, as well as eating habits in Russia (high proportion of animal fats and low consumption of fruits, berries and vegetables), which also influence their health and often causes arterial hypertension.