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news.Biotech firm Clinical Data has started the second of its two pivotal trials of Vilazodone, the company's novel drug candidate for the treatment of depression.
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This double-blind, placebo-controlled clinical trial is designed to assess the efficacy and safety of Vilazodone. It will also further evaluate genetic biomarkers of response to Vilazodone, which may lead to the development of a pharmacogenetic test that would help to determine patient’s positive response to the drug.
The trial will enroll approximately 475 adult patients diagnosed with major depressive disorder at 10 US centers. As in the already completed Phase III study, the primary endpoint will be the mean change from baseline in the Montgomery-Asberg Depression Rating Scale total score compared to placebo.
Along with the long term safety study of Vilazodone that began in December 2007, the second pivotal trial is intended to support a new drug application (NDA) for Vilazodone. Clinical Data is on-track to file its NDA with the FDA in 2009.