Multi-center non-drug-interventional extension study to assess long-term safety and effects on growth in patients who received bosentan or placebo as adjunctive therapy to inhaled nitric oxide for persistent pulmonary hypertension of the newborn in FUTURE 4 (AC-052-391) (FUTURE 4 Extension)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Clinical trial

Clinical trials

• Clinical trial regulatory scope:
  Pre-authorisation clinical trial
• Clinical trial phase:
  Therapeutic confirmatory (Phase III)
• Clinical trial randomisation:
  Non-randomised clinical trial

Study drug and medical condition

• Medical condition to be studied:
  Pulmonary hypertension

Population studied

• Short description of the study population:
  Patients with persistent pulmonary hypertension of the newborn (PPHN) who received bosentan or placebo in addition to inhaled nitric oxide grow normally.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)
• Special population of interest:
  Other
• Special population of interest, other:
  Pulmonary hypertension of the newborn (PPHN) patients
• Estimated number of subjects:
  21

Study design details

• Main study objective:
  To assess long-term safety and effects on growth in patients who received bosentan or placebo in the FUTURE 4 (AC-052-391) study.
• Data analysis plan:
  A Statistical Analysis Plan will be written and finalized before study closure.