Trial · NCT01560637

An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

NCT01560637, Phase 3, Completed, United Therapeutics; results first posted 2022-06-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension. Trials, record NCT01560637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01560637

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Trial

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

Title: An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
NCT number: NCT01560637
Status: Completed
Phases: Phase 3
Enrollment: 471 participants, actual
Lead sponsor: United Therapeutics
Conditions: Pulmonary Arterial Hypertension
Interventions: UT-15C (treprostinil diolamine)
First posted: 2012-03-22
Last updated: 2022-06-02
Results first posted: 2022-06-02

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Number of Adverse Events	Participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years	All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final visit. The overall summary of AEs includes the number of subjects with any AE, the number of subjects with any study drug-related AEs, the number of subjects with AEs leading to study drug withdrawal, the number of subjects with any serious AEs, the number of subjects with any severe AEs, and the number of subjects with any study drug-related severe/serious AEs. AEs were coded using the Medical Dictionary for Regulatory Activities.
Secondary	Change in 6-Minute Walk Distance From Baseline	Baseline to Week 48	A summary of change from Baseline in 6MWD at Week 48 for the Safety Population is provided. The Safety Population is all subjects who received oral treprostinil in TDE-PH-311.
Secondary	Change in Borg Dyspnea Score From Baseline to Week 48	Baseline to Week 48	Change in Borg Dyspnea Score from at Week 48 is provided for the Safety Population (all subjects who received oral treprostinil in TDE-PH-311). The Borg Dyspnea Scale is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and was administered during six-minute walk testing (6MWT), one of the most common and frequently used measures to assess disease severity in PAH. The numbers on the scale are as follows: 0 (no shortness of breath \[SOB\]), 0.5 (very very slight SOB), 1 (very slight SOB), 3 (moderate SOB), 4 (somewhat severe SOB), 5 (severe SOB), 7 (very severe SOB), 9 (very very severe SOB), 10 (maximal SOB).
Secondary	Change From Baseline to Week 48 in WHO Functional Class	Baseline to Week 48	Change from Baseline at Week 48 in WHO FC in the Safety Population (all subjects who received oral treprostinil in TDE-PH-311). The World Health Organization functional classification (WHO-FC) is a clinician-rated assessment used widely to assess PAH severity and functioning. Class I (least severe): Patients are without limitation of physical activity. Class II: Patients are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III: Marked limitation of physical activity. They are comfortable at rest. Class IV (most severe): Inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure.
Secondary	Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48	Baseline to Week 48	Change in N-terminal pro-brain natriuretic peptide from Baseline at Week 48 for the Safety Population (any subject who received oral treprostinil in TDE-PH-311)

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Adverse Events	Participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years	All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population.	events	NUMBER
SECONDARY	Change in 6-Minute Walk Distance From Baseline	Baseline to Week 48	All participants are subjects who received oral treprostinil in TDE-PH-311. For post-Baseline visits, only subjects with measurements at Baseline and the corresponding visit are included. Baseline is defined as the last measurement prior to the first dose of oral treprostinil in TDE-PH-311.	meters	MEAN
SECONDARY	Change in Borg Dyspnea Score From Baseline to Week 48	Baseline to Week 48	Safety Population (all subjects who received oral treprostinil in TDE-PH-311). For post-Baseline visits, only subjects with measurements at Baseline and the corresponding visit are included. Baseline is defined as the last measurement prior to the first dose of oral treprostinil in TDE-PH-311.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 48 in WHO Functional Class	Baseline to Week 48	Safety Population was analyzed. Baseline is defined as the last measurement prior to the first dose of oral treprostinil in TDE PH 311.	score on a scale	MEAN
SECONDARY	Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48	Baseline to Week 48	Subjects in the Safety Population were analyzed. For post-Baseline visits, only subjects with measurements at Baseline and the corresponding visit are included. Baseline is defined as the last measurement prior to the first dose of oral treprostinil in TDE-PH-311.	pg/mL	MEAN

Source ClinicalTrials.gov

Results by group11

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

Outcome	Group	Category	Value	Spread	Units
Number of Adverse Events	UT-15C	Adverse Event	450		events
Number of Adverse Events	UT-15C	Study Drug Related AE	362		events
Number of Adverse Events	UT-15C	AE Leading to Study Drug Withdrawal	126		events
Number of Adverse Events	UT-15C	Serious AE	206		events
Number of Adverse Events	UT-15C	Severe AE	182		events
Number of Adverse Events	UT-15C	Study Drug Related Severe AE	67		events
Number of Adverse Events	UT-15C	Study Drug Related Serious AE	37		events
Change in 6-Minute Walk Distance From Baseline	UT-15C		20.1	Standard Deviation 79.6	meters
Change in Borg Dyspnea Score From Baseline to Week 48	UT-15C		-0.49	Standard Deviation 1.92	score on a scale
Change From Baseline to Week 48 in WHO Functional Class	UT-15C		-0.2	Standard Deviation 0.6	score on a scale

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	UT-15C	470
Overall Study	COMPLETED	UT-15C	272
Overall Study	NOT COMPLETED	UT-15C	198

Source ClinicalTrials.gov

Adverse events1,004

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	UT-15C	51	470	55
other	Thrombocytopenia	Blood and lymphatic system disorders	UT-15C	17	470	19
other	Iron deficiency anaemia	Blood and lymphatic system disorders	UT-15C	9	470	11
other	Leukopenia	Blood and lymphatic system disorders	UT-15C	8	470	10
other	Splenomegaly	Blood and lymphatic system disorders	UT-15C	4	470	4
other	Coagulopathy	Blood and lymphatic system disorders	UT-15C	2	470	2
other	Pancytopenia	Blood and lymphatic system disorders	UT-15C	2	470	2
other	Anaemia of malignant disease	Blood and lymphatic system disorders	UT-15C	1	470	1
other	Antiphospholipid syndrome	Blood and lymphatic system disorders	UT-15C	1	470	1
other	Erythropenia	Blood and lymphatic system disorders	UT-15C	1	470	1

1 to 10 of 1,004Source ClinicalTrials.gov

See all 1,004 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	UT-15C	74	470
Total, other adverse events	UT-15C	467	470
Total, serious adverse events	UT-15C	206	470

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38055186	DERIVED

Source PubMed

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 comparisons0

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

None in this release.

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/NCT01560637

GET https://conductscience.org/api/trials/v1/NCT01560637/events?page=2

API reference For AI assistants