CV Therapeutics has announced that the data safety monitoring board (DSMB) overseeing the MERLIN TIMI-36 study of Ranexa (ranolazine extended-release tablets) has had its last scheduled meeting and recommended that the study continue to completion as planned.
MERLIN TIMI-36 is a multinational, double-blind, randomized, placebo-controlled, parallel-group clinical trial 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 syndrome (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN TIMI-36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study is also evaluating the safety of long-term treatment with Ranexa compared with placebo.
Within 48 hours of the onset of angina due to ACS, eligible hospitalized patients were enrolled in the study and randomized to receive intravenous Ranexa or placebo, followed by long-term outpatient treatment with Ranexa extended-release tablets or placebo. All patients also receive standard therapy during both hospital-based and outpatient treatment. The doses of Ranexa extended-release tablets used in MERLIN TIMI-36 have been studied in previous Phase III clinical trials.