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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/26193
• EU PAS number:
  EUPAS7910
• Study ID:
  26193
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Korea, Republic of

  Poland

  United Kingdom

  United States
• Study description:
  The Extension of the research project FUTURE 4 to find out whether patients with persistent pulmonary hypertension of the newborn (PPHN) who received bosentan or placebo in addition to inhaled nitric oxide grow normally and to study whether they have late side effects.
• Study status:
  Finalised

Research institutions and networks

Institutions

Actelion Pharmaceuticals

Great Ormond Street Hospital London, WC1N 3JH, United Kingdom, Norfolk and Norwich University Hospitals Norwich,UK, Všeobecná fakultní nemocnice Praha, Czech Republic, Klinika Neonatologii i Intensywnej Terapii Noworodka Warszawa, Poland, Ginekologiczno-Polozniczy Szpital Kliniczny Poznan, Poland, Samsung Medical Center Seoul, Republic of South Korea, Advocate Children’s Hospital Oaklawn, USA, Ann and Robert H. Lurie Children’s Hospital of Chicago Chicago, USA

Study timelines

Date when funding contract was signed

Actual: 11/03/2013

Study start date

Actual: 14/12/2013

Date of final study report

Actual: 18/05/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ACTELION Pharmaceuticals Ltd.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable