(duplicate) Future 4

• Research type

  Research Study

• Full title

  Multicenter, double-blind, placebo-controlled, randomized, prospective study of bosentan as adjunctive therapy to inhaled nitric oxide in the management of persistent pulmonary hypertension of the newborn (PPHN).

• IRAS ID

  83031

• Contact name

  Christine Pierce

• Sponsor organisation

  Actelion Pharmaceutical Ltd

• Eudract number

  2011-000203-41

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The standard treatment for Persistent Pulmonary Hypertension of the Newborn (PPHN) is to improve oxygenation using breathing assistance (mechanical ventilation) and to open up the blood vessels of the lungs using Inhaled Nitric Oxide (iNO). However, some babies do not respond well to this treatment or remain dependent on it. Bosentan is a drug that reduces the unwanted effects of a protein called endothelin. There is an increased amount of endothelin in the blood of patients with Pulmonary Arterial Hypertension (PAH) which contributes to the narrowing of the small blood vessels in the lungs. Bosentan blocks the effect of endothelin improving the flow of blood in the lungs. The main purpose of this study is to evaluate the efficacy and safety of bosentan in babies with PPHN. The maximum duration of the study is 28 weeks, which includes screening period (up to 7 days), a maximum duration of 14 days with study treatment, 7 days follow up following end of treatment and then a further follow up phone call after 60 days.Each study participant will be randomised on day 1 to receive bosentan or placebo. The chances of receiving Bosentan are 2 out of 3. Bosentan is an oral drug that will be administered to the baby via a gastric tube inserted into the nose or mouth.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/LO/1019

• Date of REC Opinion

  12 Aug 2011

• REC opinion

  Further Information Favourable Opinion