Announcing Commencement of Dosing in Hypotension in Premature Neonates (“HiP”) Phase III Clinical Trial

October 2, 2015 by admin

October 2, 2015.

We are delighted to announce that the HiP trial is fully up and running and has dosed its 15th patient.  This multi-center, randomized controlled trial is being led by Cork University Hospital and is being conducted in several centers in Europe and Canada. We expect to enroll approximately 750 babies.

About 150,000 pediatric patients, mostly newborn babies and infants, are treated for hypotension in Europe each year. Hypotension can occur as a result of any one of a number of conditions. Those conditions are often life-threatening and require urgent treatment. Currently, pediatric patients are treated with drugs that are not specifically approved for children and are supplied in a form that is appropriate for an adult.

The purpose of the trial is to further refine the optimal treatment protocols for this vulnerably population and it will lead to the development of an age-appropriate dosage form of the most commonly used drug for treating hypotension in pediatric patients.  The resulting product will be eligible for a Pediatric Use Marketing Authorization (“PUMA”) in the EU.

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