Trial logistics, implementation, and conduct of the OCTAVE mega study in Germany. Prospective, randomised, double-blind study to compare the efficacy and tolerability of omapatrilat and enalapril.

摘要

Using the example of the largest clinical trial so far conducted to obtain marketing approval (OCTAVE--Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril) this paper describes the way the trial was conducted in Germany and the set-up of the trial logistics. OCTAVE was a prospective, randomised, double-blind study in which the efficacy and tolerability of omapatrilat (CAS 167305-00-2) compared to enalapril (CAS 75847-73-3) were studied in 25 302 patients with uncontrolled blood pressure. Patient recruitment was completed on schedule in just under four months in this global study. An appropriate study design, tailor-made logistics, a special monitoring system and effective project and data management allowed the selection and initiation of 430 study centres in Germany. As a result 4868 patients were randomised within about six months of finalising the study protocol.