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news.CardioMetabolics has completed patient enrollment in the Mini-Metr(x)ics Phase II clinical trial, evaluating the company's proprietary intravenous formulation of dicholoracetate, in high risk geriatric patients undergoing open heart surgical procedures.
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The Phase II trial is a randomized, double blind, placebo controlled trial evaluating high risk geriatric patients following open heart surgery procedures. Patients in the treatment arm received a bolus infusion of intravenous dicholoracetate (DCA i v). immediately post surgery followed by a continuous infusion of DCA i v for a 24-hour period. The primary endpoint of the trial, which was not powered for statistical significance, is to demonstrate a reduction in the recovery time spent in the intensive care unit post surgery by the treatment group compared to placebo.
DCA i v has been evaluated in three clinical trials involving 109 cardiac patients. In addition to the completed and ongoing trials, CardioMetabolics has already secured a special protocol assessment from the FDA to conduct two Phase III trials.
Kimmo Lucas, president and CEO of CardioMetabolics, said: “The primary objective of this trial is to collect key information to assist us in finalizing the design of our Phase III protocol. Our goal is to announce the results from the Phase II trial in the second half of 2008 and complete the necessary preparations to enroll our first patient in the first Phase III trial in mid 2009.”