International clinical trial was carried out in the cooperation with the experienced clinicists, scientific experts and international contract research organisations corresponding with the ICH/ GCP (Good clinical practice) and the EU legislation for the clinical trials of I – IV phases.
A randomized, multinational, multicenter, double blind, placebo-controlled clinical trial with Mildronate® was performed in 37 research centres in Latvia, Lithuania, Russia and Ukraine. Efficiency and safety of Mildronate® in long term treatment of angina was investigated. Grindeks altogether has invested 1.6 million lats in the research.
JSC Grindeks Research and Development Director Dr. Nilss Poritis: “Selection of patients, clinical documentation and capture of all data was done accurately according to the research protocol and the international standard of “Good clinical practice”. Process of the research in the centres was monitored thoroughly and its quality was controlled several times in audits of the research centres and of the company Grindeks.
Director of Latvian Institute of Organic Synthesis, the creator of Mildronate®, scientific expert Ivars Kalvins: “As the author of this medication I have always been sure about the therapeutic effectiveness of Mildronate® that year after year is confirmed by both clinical practice and clinical trials made so far. Results of the just-finished multinational clinical trial once more approve effectiveness and the high safety of Mildronate® in the treatment of angina in combination with the standard therapy.
JSC Grindeks Chairman of the Board Janis Romanovskis: “Mildronate® is the main medication of the company. I want to mark also its significance to Latvia – it has been repeatedly recognized as a product with the fastest growing export amount in Latvia.”
JSC Grindeks Chairman of the Council Kirovs Lipmans: “Every year the company strategically invests about 10% from the total turnover in the Research and Development. Investment in the research of Mildronate® has turned out to be very successful. Positive clinical trials will serve also as a support for Grindeks to make the next step – to introduce the new generation of Mildronate®.
According to the practice of clinical trials, presently the scientific publication including the results of the clinical trial of Mildronate® is under preparation. They will be widely communicated to the circles of scientists and doctors in different conferences and symposiums.
Angina is one of the most popular symptoms of the coronary artery disease. Angina is a disease marked by attacks of chest pain or pressing feeling in the chest, precipitated by deficient oxygenation of the heart muscles. Frequently angina is provoked by physical activity of the patient. Without a treatment angina can become more frequent, but symptoms – more severe. Angina can point also at more serious heart disease and essentially impacts the quality of life of a human.
About JSC Grindeks
Grindeks is the leading pharmaceutical company in the Baltic States. The main directions of its operation are research, development, manufacturing and sales of original products, as well as generics and active pharmaceutical ingredients. Grindeks specializes in the heart and cardiovascular, psychotropic and anti-cancer therapeutic groups of medications.
Grindeks concern consists of four subsidiary companies in Latvia, Estonia and Russia; as well as representatives and representative offices in 14 countries. Products of the company are exported to more than 40 countries and its export comprises more than 96% of the total turnover. The main markets are the Baltic States, Russia and other CIS countries, as well as Japan and USA. The shares of JSC Grindeks are listed in the Official List of „Nasdaq OMX Riga”.
JSC Grindeks Head of the Communications Department
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