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IV Remodulin for Pulmonary Hypertension

Phase 2
Waitlist Available
Research Sponsored by United Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to hours 12, 24, and 72; days 7 and 14; and/or prior to study drug discontinuation/weaning
Awards & highlights

Study Summary

This trial will test if IV Remodulin is safe and effective in treating PPHN in newborns.

Eligible Conditions
  • Pulmonary Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to hours 12, 24, and 72; days 7 and 14; and/or prior to study drug discontinuation/weaning
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to hours 12, 24, and 72; days 7 and 14; and/or prior to study drug discontinuation/weaning for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects Experiencing Clinical Worsening
Secondary outcome measures
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Change in Oxygenation Index (OI)
Change in P/F Ratio
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IV RemodulinActive Control1 Intervention
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Group II: PlaceboPlacebo Group1 Intervention
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.

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Who is running the clinical trial?

United TherapeuticsLead Sponsor
109 Previous Clinical Trials
14,413 Total Patients Enrolled
~4 spots leftby Jun 2025
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