First phase 3 study of CaPre in patients with severe hypertriglyceridemia
Phase of Trial: Phase III
Latest Information Update: 30 Mar 2017
At a glance
- Drugs Omega-3 phospholipid (Primary)
- Indications Hypertriglyceridaemia
- Focus Registrational; Therapeutic Use
- Sponsors Acasti Pharma
- 30 Mar 2017 Data from this and another phase III trial (CT profile 283403) will support the New Drug Application (NDA) for CaPre for the treatment of hypertriglyceridemia.
- 12 Jan 2017 According to an Acasti Pharma media release, company plans to discuss the results of bridging study (see profile 265243) and gain guidance on the protocol of this trial, from the FDA in a meeting scheduled in the first quarter of 2017.
- 11 Oct 2016 According to an Acasti Pharma media release, the company plans to initiate this study in patients with severe hypertriglyceridemia during the second half of 2017.