The clinical trial, named MERLIN TIMI-36, is designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 6,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy.
The primary efficacy endpoint is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia. The study will also evaluate the safety of long-term treatment with Ranexa compared to placebo.
According to a special protocol assessment (SPA) agreement with the FDA, if treatment with Ranexa (ranolazine extended-release tablets) in this study is not associated with an adverse trend in death or arrhythmia compared to placebo, the study’s safety database could support potential approval of Ranexa as first-line chronic angina therapy, even if the primary endpoint is not met.
In addition, if the primary endpoint is met, Ranexa could potentially also be approved for treatment of acute coronary syndromes (ACS) and secondary prevention.
CV Therapeutics expects top line data from the study to be available in the first quarter of 2007.