Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS

1.5 Clinical Trial Example: Nicardipine

JMP Clinical ships with sample data from a randomized, placebo-controlled clinical trial of nicardipine hydrochloride, a calcium channel blocker used to treat high blood pressure, angina, and congestive heart failure [41]. The drug comes in both oral and intravenous formulations. Because nicardipine also shows activity on blood vessels in the brain, this clinical trial was designed to ascertain whether there was any benefit in using nicardipine in the treatment of patients who experienced a subarachnoid hemorrhage (SAH, bleeding between the brain and the tissues that cover the brain). Patients were dosed with either intravenous nicardipine (up to 15 mg/kg/hr) or placebo for up to two weeks with the goal ...