Phase III Study in cardiology
Background: Smooth Drug Development was involved in the organization of a Phase III clinical trial of a combination drug in patients with uncontrolled essential hypertension.
About a trial: We prepared the package of documents for submission for trial approval and import of the drug, developed the database and performed data processing, performed pharmacovigilance and site monitoring. We also wrote a final report on the results of the study.
Challenges: The study did not present any difficulties in the planning or execution phase, as our team developed and coordinated the protocol with opinion leaders and physicians. 23 sites were opened for the study and 150 subjects were randomized over a 6-month period. Patient enrollment continued even over the New Year holidays. Based on the results of this study, the drug will be registered in the EU and EAEU.