This is to announce that OCT has obtained a regulatory approval for a clinical study in patients with essential arterial hypertension grade II.
This is an international, multicenter, open, randomized study to evaluate the therapeutic equivalence of the test and the reference medicinal product in patients with essential arterial hypertension grade II, initiated by one of the German Sponsors OCT has been working with in a number of clinical research projects.
This therapeutic equivalence study will be conducted in two of the countries of OCT operation – Russia and Ukraine. It is planned to screen up to 185 patients with grade II essential hypertension to be able to randomize 140 patients into the study. For this aim, 10 medicinal centers will be initiated in Russia, and 5 study centers will be enrolling patients in Ukraine in the course of 5 months, giving a total of 15 sites engaged in the current clinical trial.
The main objective of this study is to determine the therapeutic equivalence of the free combination of the active ingredients of the investigational drug with the fixed combination of the same ingredients in the reference drug and the safety in patients with essential arterial hypertension grade II.
Arterial hypertension (HTN) or high blood pressure is a chronic medical condition in which the blood pressure in the arteries is elevated.
Russia has always been an attractive region for cardiology studies due to the high incidence rates in this region.
Cardiovascular diseases are a major public health and socioeconomic problem, since they occupy a
According to statistics, nowadays Cardiovascular diseases account for 57 percent of all deaths in Russia, and there is a number of reasons for that.
First of all, although historically, the Russians have not always been the heaviest drinkers in Europe, in the past 20 years, alcohol consumption in Russia remained very high - about 10 to 15 liters per person per year, as compared to 10.3 liters in Sweden and 12.8 liters in Germany. Statistics shows that about 70 percent of men, 47 percent of women and 30 percent of teenagers are consuming alcohol, and the total of 70 percent of the population is consuming strong alcohol drinks.
Moreover, Russia is a country with one of the world’s highest rates of male smokers. According to a survey on a nationally representative sample, 63.2 percent of men and 9.1 percent of women smoke tobacco in Russia.
Eating habits of Russians is characterized by a high proportion of animal fats and low consumption of fruits, berries and vegetables, which also influence their health and often causes arterial hypertension.
Russia is a country with a high prevalence of hypertension. According to the results of surveys of the population of Moscow, St. Petersburg and Tver, about 45 percent of men and 37 percent of women suffer from hypertension and the contribution of hypertension to total mortality rates is about 35 percent.
Clinical trials initiated by foreign and home Sponsors help patients cure from this life-threatening disease.