Trial · NCT02261883

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

NCT02261883, Phase 2, Terminated, United Therapeutics; results first posted 2024-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn. Trials, record NCT02261883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02261883

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
NCT number: NCT02261883
Status: Terminated
Phases: Phase 2
Enrollment: 42 participants, actual
Lead sponsor: United Therapeutics
Conditions: Persistent Pulmonary Hypertension of the Newborn
Interventions: IV Remodulin, Placebo
First posted: 2014-10-10
Last updated: 2024-03-05
Results first posted: 2024-03-05

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects Experiencing Clinical Worsening	From Baseline to Day 14	Clinical worsening was a composite endpoint defined by the occurrence of 1 of the following: death, initiation of ECMO per institutional policies, or need for additional treatment (initiation of additional targeted pulmonary vasodilator therapy).
Secondary	Change in Oxygenation Index (OI)	From Baseline to Hours 12, 24, and 72; Days 7 and 14; and/or prior to study drug discontinuation/weaning	OI is an assessment of how much oxygen from the lungs enters the blood when a subject inhales, calculated as: mean airway pressure (MAP) multiplied by fraction of inspired oxygen (FiO2) divided by partial pressure of oxygen in the arterial blood (PaO2), then multiplying by 100. An OI of 15 or less indicates mild hypoxia, 16 to 25 indicates moderate hypoxia, 26 to 40 indicates severe hypoxia, and more than 40 indicates very severe hypoxia.
Secondary	Change in P/F Ratio	From Baseline to Hours 12, 24, and 72	PaO2/FiO2 ratio, also referred to as P/F Ratio, is a calculation used to assess the severity of hypoxemia, which is a condition characterized by low levels of oxygen in the blood. A low P/F ratio suggests that the patient's oxygen levels are compromised relative to the amount of oxygen being provided.
Secondary	Change in Pre- and Post-ductal Oxygen Saturation (SpO2)	From Baseline to Hours 6, 12, 24, and 72	SpO2 is an assessment of how much oxygen is in the blood, measured by a pulse oximeter. Pre-ductal SpO2 is measured in the right hand or foot and is a reflection of the amount of oxygen flowing to the brain. Post-ductal SpO2 is measured in the left hand or foot, after the blood has mixed with less oxygenated blood from the rest of the body.
Secondary	Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)	From Baseline to Days 1, 2, 3, 7, and 14 (or prior to hospital discharge)	NT-proBNP is a hormone produced by the heart. Increased NT-proBNP concentration is associated with changes in right heart morphology and function. The main purpose of NT-proBNP testing is to see if the blood levels of this protein are within the expected range for a healthy individual.
Secondary	Time to Clinical Worsening	From Baseline to Day 56	Clinical worsening was assessed continuously during the study. Clinical worsening was a composite endpoint defined by the occurrence of 1 of the following: death, initiation of ECMO per institutional policies, or need for additional treatment (initiation of additional targeted pulmonary vasodilator therapy).
Secondary	Time to Initiation of ECMO	From Baseline to Day 56	Start of ECMO was assessed continuously during the study. ECMO is a life-support therapy that oxygenates blood by passing it through an artificial lung. The start time of ECMO, if needed, was recorded for each subject.
Secondary	Time to Discontinuation of Inhaled Nitric Oxide (iNO)	From Baseline to Day 56	Discontinuation of iNO was assessed continuously during the study. iNO works by relaxing the blood vessels in the lungs, which makes it easier for oxygen to be delivered to the body. The stop time of iNO was recorded for each subject.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects Experiencing Clinical Worsening	From Baseline to Day 14	Intent-to-Treat Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Oxygenation Index (OI)	From Baseline to Hours 12, 24, and 72; Days 7 and 14; and/or prior to study drug discontinuation/weaning	Intent-to-Treat Population	units on a scale	MEDIAN
SECONDARY	Change in P/F Ratio	From Baseline to Hours 12, 24, and 72	Intent-to-Treat Population	ratio	MEDIAN
SECONDARY	Change in Pre- and Post-ductal Oxygen Saturation (SpO2)	From Baseline to Hours 6, 12, 24, and 72	Intent-to-Treat Population	percentage of oxygen	MEDIAN
SECONDARY	Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)	From Baseline to Days 1, 2, 3, 7, and 14 (or prior to hospital discharge)	Intent-to-Treat Population	pg/mL	MEDIAN
SECONDARY	Time to Clinical Worsening	From Baseline to Day 56	Intent-to-Treat Population	days	MEDIAN
SECONDARY	Time to Initiation of ECMO	From Baseline to Day 56	Intent-to-Treat Population	days	MEDIAN
SECONDARY	Time to Discontinuation of Inhaled Nitric Oxide (iNO)	From Baseline to Day 56	Intent-to-Treat Population	days	MEDIAN

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Subjects Experiencing Clinical Worsening	IV Remodulin	Yes	8		Participants
Number of Subjects Experiencing Clinical Worsening	Placebo	Yes	12		Participants
Number of Subjects Experiencing Clinical Worsening	IV Remodulin	No	12		Participants
Number of Subjects Experiencing Clinical Worsening	Placebo	No	9		Participants
Change in Oxygenation Index (OI)	IV Remodulin	12 Hours	-2.0	Full Range -41 to 37	units on a scale
Change in Oxygenation Index (OI)	Placebo	12 Hours	-3.5	Full Range -29 to 34	units on a scale
Change in Oxygenation Index (OI)	IV Remodulin	24 Hours	-8.5	Full Range -40 to 23	units on a scale
Change in Oxygenation Index (OI)	Placebo	24 Hours	-5.5	Full Range -30 to 58	units on a scale
Change in Oxygenation Index (OI)	IV Remodulin	72 Hours	-7.0	Full Range -40 to 65	units on a scale
Change in Oxygenation Index (OI)	Placebo	72 Hours	-10.0	Full Range -41 to 83	units on a scale

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IV Remodulin	21
Overall Study	STARTED	Placebo	21
Overall Study	COMPLETED	IV Remodulin	15
Overall Study	COMPLETED	Placebo	18
Overall Study	NOT COMPLETED	IV Remodulin	6
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	IV Remodulin	5	20	5
other	Anaemia	Blood and lymphatic system disorders	Placebo	4	21	4
other	Thrombocytopenia	Blood and lymphatic system disorders	IV Remodulin	4	20	4
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	1	21	1
other	Constipation	Gastrointestinal disorders	IV Remodulin	2	20	2
other	Constipation	Gastrointestinal disorders	Placebo	0	21	0
other	Drug withdrawal syndrome neonatal	General disorders	IV Remodulin	3	20	3
other	Drug withdrawal syndrome neonatal	General disorders	Placebo	0	21	0
other	Drug withdrawal syndrome	General disorders	IV Remodulin	1	20	1
other	Drug withdrawal syndrome	General disorders	Placebo	2	21	2

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IV Remodulin	4	20
Total, all-cause mortality	Placebo	2	21
Total, other adverse events	IV Remodulin	19	20
Total, other adverse events	Placebo	17	21
Total, serious adverse events	IV Remodulin	8	20
Total, serious adverse events	Placebo	3	21

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
IV Remodulin vs Placebo: deaths from any cause	Trial comparisons
IV Remodulin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02261883

GET https://conductscience.org/api/trials/v1/NCT02261883/results?page=2

API reference For AI assistants