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Health Canada allows Acasti Pharma to initiate CaPre Phase II trial

Health Canada has approved Acasti Pharma's clinical trial application (CTA) to commence a Phase II trial of CaPre.

Following the approval, the company expects to start a double blind, placebo controlled and randomized Phase II trial to assess the usage of CaPre for the treatment of patients with dyslipidemia.

The trial will investigate the safety and efficacy of CaPre in patients with triglyceride levels ranging from moderately high to very high, which distinguishes CaPre from prescription drug fish oils labelled only to treat patients with very high levels of triglycerides.

Acasti president Tina Sampalis said the CaPre clinical phase II program will assess direct and complementary clinical outcomes associated with cardiometabolic disorders and will be supportive of additional clinical programs in Canada and in the US.