Grindeks Finished Clinical Trial on Mildronate®
OREANDA-NEWS. February 15, 2010. JSC "Grindeks" informs that it has successfully finished the clinical trial on the influence of the brand product Mildronate® on the treatment of angina.
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 practiсe) 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
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 practiсe". 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
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.
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