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.
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.
Bristol-Myers Squibb GmbHa, Munich, Germany.
Wolfgang
W
Kothny
Rosemarie
R
Kaaden
Petra
P
Ludwig
Dagmar
D
Chase
Michael
M
Krekler
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003625:Data Collection; D004311:Double-Blind Method; D004656:Enalapril / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D011446:Prospective Studies; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D011795:Surveys and Questionnaires; D013841:Thiazepines / Q000009:adverse effects / Q000627:therapeutic use*
D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D011725:Pyridines; D013841:Thiazepines; C106266:omapatrilat; D004656:Enalapril