<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02261883</url>
  </required_header>
  <id_info>
    <org_study_id>RIV-PN-201</org_study_id>
    <nct_id>NCT02261883</nct_id>
  </id_info>
  <brief_title>Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn</brief_title>
  <official_title>Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study aims to assess the safety and treatment effect of acute dosing with IV&#xD;
      Remodulin in neonates with persistent pulmonary hypertension of the newborn (PPHN).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll subjects with PPHN who do not show an adequate response to inhaled&#xD;
      nitric oxide with the hypothesis that the addition of intravenous (IV) Remodulin will reduce&#xD;
      the rate of clinical worsening as compared to standard of care. Additionally, this study aims&#xD;
      to evaluate the treatment effect of Remodulin and better understand the dosing and&#xD;
      pharmacokinetics in the neonatal population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">September 27, 2022</completion_date>
  <primary_completion_date type="Actual">September 27, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the rate of clinical worsening in neonates with PPHN</measure>
    <time_frame>Up to Day 14</time_frame>
    <description>Efficacy will be assessed by a composite endpoint of clinical worsening as defined by the following:&#xD;
Initiation of additional pulmonary vasodilator therapy&#xD;
Initiation of extracorporeal mechanical oxygenation (ECMO) per institutional policies&#xD;
Death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to discontinuation of inhaled nitric oxide (iNO)</measure>
    <time_frame>Up to Day 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in oxygenation index (OI)</measure>
    <time_frame>Hour 12, hour 24, hour 72, Day 7 and Day 14/ or prior to study drug discontiuation</time_frame>
    <description>OI= [MAP(mmHg) x FiO2(%) / PaO2(mmHg)] x 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time on mechanical ventilation</measure>
    <time_frame>Up to Day 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to initiation of ECMO</measure>
    <time_frame>Up to Day 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean treprostinil plasma concentration per dose achieved</measure>
    <time_frame>24 hours after initiation of Remodulin and immediately prior to wean</time_frame>
    <description>Two blood samples will be collected from each patient for treprostinil pharmacokinetic (PK) analysis. Plasma samples will be analyzed for treprostinil using a validated bioanalytical plasma assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>up to Day 56</time_frame>
    <description>Assessment of adverse events, change in vital signs, and change in labs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) [P/F ratio]</measure>
    <time_frame>Hour 12, hour 24, and hour 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP)</measure>
    <time_frame>Day 7, Day 14, prior to study drug wean, study drug discontinuation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pre and post-ductal oxygen saturation (SpO2)</measure>
    <time_frame>Hour 6, hour 12, hour 24, and hour 72</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Persistent Pulmonary Hypertension of the Newborn</condition>
  <arm_group>
    <arm_group_label>IV Remodulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IV Remodulin will be initiated at 1 ng/kg/min. The dose will be increased in up to 2 ng/kg/min increments every 2 hrs until the OI is &lt;10 (in the absence of dose-limiting side effects).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be initiated at 1 ng/kg/min. The dose will be increased in up to 2 ng/kg/min increments every 2 hrs until the OI is &lt;10 (in the absence of dose-limiting side effects).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV Remodulin</intervention_name>
    <description>Treprostinil is a chemically stable tricyclic analogue of prostacyclin.</description>
    <arm_group_label>IV Remodulin</arm_group_label>
    <other_name>treprostinil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>matching placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent(s) or guardian provides consent for the subject to participate, as per&#xD;
             institutional policy&#xD;
&#xD;
          -  At least 2 kg at Screening&#xD;
&#xD;
          -  Gestational age ≥ 34 weeks and ≤ 14 days old at Screening&#xD;
&#xD;
          -  Diagnosis of PPHN, which is either idiopathic in nature or associated with the&#xD;
             following: meconium aspiration syndrome (MAS), pneumonia, respiratory distress&#xD;
             syndrome (RDS), sepsis, birth hypoxia, perinatal encephalopathy or unilateral&#xD;
             congenital diaphragmatic hernia (CDH)&#xD;
&#xD;
          -  Currently requiring ventilator support&#xD;
&#xD;
          -  Receiving iNO with two OIs of 15 or greater separated by at least 30 minutes after&#xD;
             receiving iNO for at least 3 hours&#xD;
&#xD;
          -  Echocardiographic evidence of pulmonary hypertension with elevated right ventricle&#xD;
             pressure&#xD;
&#xD;
          -  Dedicated venous access for the administration of study drug (central line or&#xD;
             peripherally inserted central venous catheter)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or concurrent use of a phosphodiesterase-5 inhibitor (PDE5i), endothelin&#xD;
             receptor antagonist (ERA), or prostanoid&#xD;
&#xD;
          -  Significant congenital heart disease (CHD) as detected by ECHO (excluding presence of&#xD;
             minor defects such as small secundum atrial septal defect (ASD), minor valvular&#xD;
             abnormalities, or expected transitional findings such as a patent foramen ovale (PFO),&#xD;
             or patent ductus arteriosus (PDA). Subjects with small muscular, restrictive&#xD;
             ventricular septal defect (VSD) may be enrolled&#xD;
&#xD;
          -  Clinically significant, untreated active pneumothorax at Screening&#xD;
&#xD;
          -  Evidence of clinically significant bleeding&#xD;
&#xD;
          -  Necrotizing entercolitis; ≥ Bells stage II at Screening&#xD;
&#xD;
          -  Uncontrolled hypotension; mean systemic pressures ≤ 35 mmHg at Screening.&#xD;
&#xD;
          -  Uncontrolled coagulopathy and / or untreated thrombocytopenia; defined as &lt;50,000&#xD;
             platelets /µL at Screening&#xD;
&#xD;
          -  History of severe (Grade 3 or 4) intracranial hemorrhage&#xD;
&#xD;
          -  Currently receiving ECMO or has immediate plans to initiate ECMO&#xD;
&#xD;
          -  Expected duration on mechanical ventilation of less than 48 hours&#xD;
&#xD;
          -  Life expectancy is less than two months or has a lethal chromosomal anomaly&#xD;
&#xD;
          -  Contraindication to ECMO&#xD;
&#xD;
          -  Bilateral congenital diaphragmatic hernia&#xD;
&#xD;
          -  Active seizures at Screening&#xD;
&#xD;
          -  Currently participating in another clinical drug study (excluding observational&#xD;
             registries)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>14 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Children's Hospital</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All Children's Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann and Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center - Baston Children's Hospital</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032-3784</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Childrens Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cook Children's Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health Systems(UVA)</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin</name>
      <address>
        <city>Wauwatosa</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Steinhorn RH. Nitric oxide and beyond: new insights and therapies for pulmonary hypertension. J Perinatol. 2008 Dec;28 Suppl 3(Suppl 3):S67-71. doi: 10.1038/jp.2008.158.</citation>
    <PMID>19057613</PMID>
  </reference>
  <reference>
    <citation>Neonatal Inhaled Nitric Oxide Study Group. Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure. N Engl J Med. 1997 Feb 27;336(9):597-604. doi: 10.1056/NEJM199702273360901. Erratum In: N Engl J Med 1997 Aug 7;337(6):434.</citation>
    <PMID>9036320</PMID>
  </reference>
  <reference>
    <citation>Clark RH, Kueser TJ, Walker MW, Southgate WM, Huckaby JL, Perez JA, Roy BJ, Keszler M, Kinsella JP. Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. Clinical Inhaled Nitric Oxide Research Group. N Engl J Med. 2000 Feb 17;342(7):469-74. doi: 10.1056/NEJM200002173420704.</citation>
    <PMID>10675427</PMID>
  </reference>
  <reference>
    <citation>Simonneau G, Barst RJ, Galie N, Naeije R, Rich S, Bourge RC, Keogh A, Oudiz R, Frost A, Blackburn SD, Crow JW, Rubin LJ; Treprostinil Study Group. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002 Mar 15;165(6):800-4. doi: 10.1164/ajrccm.165.6.2106079.</citation>
    <PMID>11897647</PMID>
  </reference>
  <reference>
    <citation>Rubenfire M, McLaughlin VV, Allen RP, Elliott G, Park MH, Wade M, Schilz R. Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. Chest. 2007 Sep;132(3):757-63. doi: 10.1378/chest.06-2118. Epub 2007 Mar 30. Erratum In: Chest. 2007 Nov;132(5):1721.</citation>
    <PMID>17400684</PMID>
  </reference>
  <reference>
    <citation>Hiremath J, Thanikachalam S, Parikh K, Shanmugasundaram S, Bangera S, Shapiro L, Pott GB, Vnencak-Jones CL, Arneson C, Wade M, White RJ; TRUST Study Group. Exercise improvement and plasma biomarker changes with intravenous treprostinil therapy for pulmonary arterial hypertension: a placebo-controlled trial. J Heart Lung Transplant. 2010 Feb;29(2):137-49. doi: 10.1016/j.healun.2009.09.005.</citation>
    <PMID>20022264</PMID>
  </reference>
  <reference>
    <citation>Levy M, Celermajer DS, Bourges-Petit E, Del Cerro MJ, Bajolle F, Bonnet D. Add-on therapy with subcutaneous treprostinil for refractory pediatric pulmonary hypertension. J Pediatr. 2011 Apr;158(4):584-8. doi: 10.1016/j.jpeds.2010.09.025. Epub 2010 Oct 30.</citation>
    <PMID>21035821</PMID>
  </reference>
  <reference>
    <citation>Ivy DD, Claussen L, Doran A. Transition of stable pediatric patients with pulmonary arterial hypertension from intravenous epoprostenol to intravenous treprostinil. Am J Cardiol. 2007 Mar 1;99(5):696-8. doi: 10.1016/j.amjcard.2006.09.119. Epub 2007 Jan 10.</citation>
    <PMID>17317374</PMID>
  </reference>
  <reference>
    <citation>Christman BW, McPherson CD, Newman JH, King GA, Bernard GR, Groves BM, Loyd JE. An imbalance between the excretion of thromboxane and prostacyclin metabolites in pulmonary hypertension. N Engl J Med. 1992 Jul 9;327(2):70-5. doi: 10.1056/NEJM199207093270202.</citation>
    <PMID>1603138</PMID>
  </reference>
  <reference>
    <citation>Laliberte K, Arneson C, Jeffs R, Hunt T, Wade M. Pharmacokinetics and steady-state bioequivalence of treprostinil sodium (Remodulin) administered by the intravenous and subcutaneous route to normal volunteers. J Cardiovasc Pharmacol. 2004 Aug;44(2):209-14. doi: 10.1097/00005344-200408000-00010.</citation>
    <PMID>15243302</PMID>
  </reference>
  <reference>
    <citation>Wade M, Baker FJ, Roscigno R, DellaMaestra W, Hunt TL, Lai AA. Absolute bioavailability and pharmacokinetics of treprostinil sodium administered by acute subcutaneous infusion. J Clin Pharmacol. 2004 Jan;44(1):83-8. doi: 10.1177/0091270003261343.</citation>
    <PMID>14681345</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>October 30, 2013</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PPHN</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Persistent Fetal Circulation Syndrome</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Treprostinil</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02261883
org study id: RIV-PN-201
nct id: NCT02261883
lead sponsor: 
has dmc: Yes
This pilot study aims to assess the safety and treatment effect of acute dosing with IV
      Remodulin in neonates with persistent pulmonary hypertension of the newborn (PPHN).
This study will enroll subjects with PPHN who do not show an adequate response to inhaled
      nitric oxide with the hypothesis that the addition of intravenous (IV) Remodulin will reduce
      the rate of clinical worsening as compared to standard of care. Additionally, this study aims
      to evaluate the treatment effect of Remodulin and better understand the dosing and
      pharmacokinetics in the neonatal population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Evaluate the rate of clinical worsening in neonates with PPHN
time frame: Up to Day 14
description: Efficacy will be assessed by a composite endpoint of clinical worsening as defined by the following:
Initiation of additional pulmonary vasodilator therapy
Initiation of extracorporeal mechanical oxygenation (ECMO) per institutional policies
Death
measure: Time to discontinuation of inhaled nitric oxide (iNO)
time frame: Up to Day 56
measure: Change in oxygenation index (OI)
time frame: Hour 12, hour 24, hour 72, Day 7 and Day 14/ or prior to study drug discontiuation
description: OI= [MAP(mmHg) x FiO2(%) / PaO2(mmHg)] x 100
measure: Time on mechanical ventilation
time frame: Up to Day 56
measure: Time to initiation of ECMO
time frame: Up to Day 56
measure: Mean treprostinil plasma concentration per dose achieved
time frame: 24 hours after initiation of Remodulin and immediately prior to wean
description: Two blood samples will be collected from each patient for treprostinil pharmacokinetic (PK) analysis. Plasma samples will be analyzed for treprostinil using a validated bioanalytical plasma assay.
measure: Safety
time frame: up to Day 56
description: Assessment of adverse events, change in vital signs, and change in labs.
measure: Change in partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) [P/F ratio]
time frame: Hour 12, hour 24, and hour 72
measure: Change in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP)
time frame: Day 7, Day 14, prior to study drug wean, study drug discontinuation
measure: Change in pre and post-ductal oxygen saturation (SpO2)
time frame: Hour 6, hour 12, hour 24, and hour 72
arm group label: IV Remodulin
arm group type: Active Comparator
description: IV Remodulin will be initiated at 1 ng/kg/min. The dose will be increased in up to 2 ng/kg/min increments every 2 hrs until the OI is <10 (in the absence of dose-limiting side effects).
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be initiated at 1 ng/kg/min. The dose will be increased in up to 2 ng/kg/min increments every 2 hrs until the OI is <10 (in the absence of dose-limiting side effects).
intervention type: Drug
intervention name: IV Remodulin
description: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
arm group label: IV Remodulin
other name: treprostinil
intervention type: Drug
intervention name: Placebo
description: matching placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 14 Days
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Steinhorn RH. Nitric oxide and beyond: new insights and therapies for pulmonary hypertension. J Perinatol. 2008 Dec;28 Suppl 3(Suppl 3):S67-71. doi: 10.1038/jp.2008.158.
PMID: 19057613
citation: Neonatal Inhaled Nitric Oxide Study Group. Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure. N Engl J Med. 1997 Feb 27;336(9):597-604. doi: 10.1056/NEJM199702273360901. Erratum In: N Engl J Med 1997 Aug 7;337(6):434.
PMID: 9036320
citation: Clark RH, Kueser TJ, Walker MW, Southgate WM, Huckaby JL, Perez JA, Roy BJ, Keszler M, Kinsella JP. Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. Clinical Inhaled Nitric Oxide Research Group. N Engl J Med. 2000 Feb 17;342(7):469-74. doi: 10.1056/NEJM200002173420704.
PMID: 10675427
citation: Simonneau G, Barst RJ, Galie N, Naeije R, Rich S, Bourge RC, Keogh A, Oudiz R, Frost A, Blackburn SD, Crow JW, Rubin LJ; Treprostinil Study Group. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002 Mar 15;165(6):800-4. doi: 10.1164/ajrccm.165.6.2106079.
PMID: 11897647
citation: Rubenfire M, McLaughlin VV, Allen RP, Elliott G, Park MH, Wade M, Schilz R. Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. Chest. 2007 Sep;132(3):757-63. doi: 10.1378/chest.06-2118. Epub 2007 Mar 30. Erratum In: Chest. 2007 Nov;132(5):1721.
PMID: 17400684
citation: Hiremath J, Thanikachalam S, Parikh K, Shanmugasundaram S, Bangera S, Shapiro L, Pott GB, Vnencak-Jones CL, Arneson C, Wade M, White RJ; TRUST Study Group. Exercise improvement and plasma biomarker changes with intravenous treprostinil therapy for pulmonary arterial hypertension: a placebo-controlled trial. J Heart Lung Transplant. 2010 Feb;29(2):137-49. doi: 10.1016/j.healun.2009.09.005.
PMID: 20022264
citation: Levy M, Celermajer DS, Bourges-Petit E, Del Cerro MJ, Bajolle F, Bonnet D. Add-on therapy with subcutaneous treprostinil for refractory pediatric pulmonary hypertension. J Pediatr. 2011 Apr;158(4):584-8. doi: 10.1016/j.jpeds.2010.09.025. Epub 2010 Oct 30.
PMID: 21035821
citation: Ivy DD, Claussen L, Doran A. Transition of stable pediatric patients with pulmonary arterial hypertension from intravenous epoprostenol to intravenous treprostinil. Am J Cardiol. 2007 Mar 1;99(5):696-8. doi: 10.1016/j.amjcard.2006.09.119. Epub 2007 Jan 10.
PMID: 17317374
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responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Persistent Fetal Circulation Syndrome
mesh term: Hypertension
mesh term: Treprostinil