CV Therapeutics Inc. says the MERLIN TIMI-36 study of ranolazine will proceed to the study close-out phase now that the required number of endpoints have accumulated, “Medical News Today” reports.
The primary efficacy endpoint in MERLIN TIMI-36 is time to first occurrence of any element of the composite endpoint of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation acute coronary syndromes (ACS) receiving standard therapy. The study also evaluates the safety of long-term treatment with Ranexa (ranolazine extended-release tablets) compared to placebo.
According to a special protocol assessment (SPA) agreement with the FDA, if the primary endpoint is met, Ranexa could potentially be approved for treatment of ACS and secondary prevention. And, under the SPA agreement, if treatment with Ranexa 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, according to the SPA.
Study patients will come in for a final study visit and the 440 enrolling study sites in 17 countries will be closed out, followed by unblinding and analysis of the data. Top line data could be available in the first quarter of 2007.
For details, visit www.cvt.com