Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Persistent Pulmonary Hypertension of the Newborn (FUTURE 4)

This study has been terminated.
(To be compliant with the timelines as agreed with Pediatric Committee (PC) within the Pediatric Investigational Plan)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01389856
First received: June 30, 2011
Last updated: February 11, 2014
Last verified: February 2014

June 30, 2011
February 11, 2014
December 2011
December 2013   (final data collection date for primary outcome measure)
Proportion of patients with treatment failure [ Time Frame: From baseline to up to 14 days ] [ Designated as safety issue: No ]

Exploratory Endpoint:

Proportion of patients with treatment failure:

  • Need for extra corporeal membrane oxygenation (ECMO) or
  • Initiation of alternative pulmonary vasodilator
Same as current
Complete list of historical versions of study NCT01389856 on ClinicalTrials.gov Archive Site
Time to complete weaning from inhaled nitric oxide (iNO) [ Time Frame: From baseline to up to 14 days ] [ Designated as safety issue: No ]

Exploratory Endpoint:

Time to complete weaning from inhaled nitric oxide (iNO)

Same as current
Not Provided
Not Provided
 
Persistent Pulmonary Hypertension of the Newborn
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)

The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Persistent Fetal Circulation Syndrome
  • Drug: Bosentan
    2 mg/kg of weight at birth twice daily (b.i.d); dispersible and quadrisectible 32 mg tablet of bosentan by nasogastric or orogastric tube.
    Other Name: Tracleer
  • Drug: Matching placebo
    2 mg/kg of weight at birth twice daily (b.i.d); dispersible and quadrisectible 32 mg tablet of matching placebo by nasogastric or orogastric tube.
  • Experimental: 1
    Bosentan
    Intervention: Drug: Bosentan
  • Placebo Comparator: 2
    Matching placebo
    Intervention: Drug: Matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
January 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Signed informed consent by the parent(s) or the legal representative(s).
  2. Term and near term newborns (gestational age > 34 weeks).
  3. Post natal age ≥ 12 hours and < 7 days.
  4. Weight at birth ≥ 2,000 g.
  5. Idiopathic PPHN or PPHN due to parenchymal lung disease
  6. Documented diagnosis of pulmonary hypertension (PH) confirmed by echocardiography:
  7. Need for continued iNO at a dose > 10ppm after at least 4 hours of continuous iNO treatment.
  8. Two oxygenation index (OI) values ≥ 12 taken at least 30 minutes apart, in the 12 hours prior to randomization and while the patient is receiving iNO treatment.
  9. Mechanical ventilation with fraction of inspired oxygen (FiO2) ≥ 50% at randomization.

Exclusion Criteria:

  1. PH associated with conditions other than PPHN.
  2. Immediate need for cardiac resuscitation or extracorporeal membrane oxygenation (ECMO).
  3. Lethal congenital anomalies.
  4. Congenital Diaphragmatic Hernia.
  5. Significant structural cardiac anomalies..
  6. Medically significant pneumothorax.
  7. Active seizures.
  8. Expected duration of mechanical ventilation of less than 48 hours.
  9. Mean systemic blood pressure < 35 mmHg despite therapy with volume infusions and cardiotonic support.
  10. Hepatic failure or all conditions with ALT values > 2 x ULN.
  11. Renal function impairment such as serum creatinine > 3 x ULN or anuria.
  12. Known intracranial hemorrhage grade III or IV.
  13. Either hemoglobin or hematocrit level < 75% of the LLN.
  14. Thrombocytopenia (platelet count < 50,000 cells /µL).
  15. Leukopenia (WBC < 2,500 cells/ µL).
  16. Any condition precluding the use of a nasogastric/orogastric tube.
  17. Administration of prohibited medication prior to randomization.
Both
up to 7 Days
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Czech Republic,   France,   Germany,   Korea, Republic of,   Poland,   Russian Federation,   Singapore,   Switzerland,   United Kingdom
 
NCT01389856
AC-052-391
Yes
Actelion
Actelion
Not Provided
Not Provided
Actelion
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP