Persistent Pulmonary Hypertension of the Newborn (FUTURE 4)

This study is currently recruiting participants.

Verified May 2013 by Actelion

Sponsor:

Information provided by (Responsible Party):

Actelion

ClinicalTrials.gov Identifier:

NCT01389856

First received: June 30, 2011

Last updated: May 30, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 30, 2011
Last Updated Date	May 30, 2013
Start Date ^ICMJE	December 2011
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 7, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01389856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 7, 2011)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Persistent Pulmonary Hypertension of the Newborn
Official Title ^ICMJE	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)
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Persistent Fetal Circulation Syndrome
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: 1 Bosentan Intervention: Drug: Bosentan Placebo Comparator: 2 Matching placebo Intervention: Drug: Matching placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	August 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Signed informed consent by the parent(s) or the legal representative(s). Term and near term newborns (gestational age > 34 weeks). Post natal age ≥ 12 hours and < 7 days. Weight at birth ≥ 2,500 g. Idiopathic PPHN or PPHN due to parenchymal lung disease Pulmonary hypertension (PH) confirmed by echocardiography: Need for continued iNO at a dose > 10ppm after at least 4 hours of continuous iNO treatment. Two oxygenation index (OI) values ≥ 15 taken at least 30 minutes apart, in the 12 hours prior to randomization and while the patient is receiving iNO treatment. Mechanical ventilation with fraction of inspired oxygen (FiO2) ≥ 50%. Exclusion Criteria: PH associated with conditions other than PPHN. Immediate need for cardiac resuscitation or extracorporeal membrane oxygenation (ECMO) (profound hypoxemia [PaO2] < 30 mm Hg; OI > 40). Lethal congenital anomalies. Congenital Diaphragmatic Hernia. Significant congenital heart disease or significant left to right shunt. Medically significant pneumothorax. Active seizures. Expected duration of mechanical ventilation of less than 48 hours. Mean systemic blood pressure < 35 mmHg despite therapy with volume infusions and cardiotonic support. Hepatic failure or all conditions with either AST or ALT values > 2 x ULN. Renal function impairment such as serum creatinine > 3 x ULN or anuria. Known intracranial hemorrhage grade III or IV. Either hemoglobin or hematocrit level < 75% of the LLN. Thrombocytopenia (platelet count < 50,000 cells /µL). Leukopenia (WBC < 2,500 cells/ µL). Any condition precluding the use of a nasogastric/orogastric tube. Administration of prohibited medication prior to randomization.
Gender	Both
Ages	up to 7 Days
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States, Australia, Belgium, Czech Republic, France, Germany, Korea, Republic of, Netherlands, Poland, Switzerland, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01389856
Other Study ID Numbers ^ICMJE	AC-052-391
Has Data Monitoring Committee	Yes
Responsible Party	Actelion
Study Sponsor ^ICMJE	Actelion
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Actelion
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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