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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
At least 2 kg at Screening
Dedicated venous access for the administration of study drug (central line or peripherally inserted central venous catheter)
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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.

Find a Location

Who is running the clinical trial?

United TherapeuticsLead Sponsor
107 Previous Clinical Trials
13,345 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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~4 spots leftby Mar 2025