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Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn

NCT02261883 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-03-05

Study results available
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Summary

This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).

Conditions

  • Persistent Pulmonary Hypertension of the Newborn

Interventions

DRUG

IV Remodulin

Treprostinil is a chemically stable tricyclic analogue of prostacyclin.

DRUG

Placebo

Sodium citrate, sodium chloride, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-29
Primary Completion
2022-09-27
Completion
2023-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261883 on ClinicalTrials.gov