Trial · NCT01560624

Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy

NCT01560624, Phase 3, Completed, United Therapeutics; results first posted 2020-02-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy. Trials, record NCT01560624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01560624

On this page

Trial

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

Title: Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy
NCT number: NCT01560624
Status: Completed
Phases: Phase 3
Enrollment: 690 participants, actual
Lead sponsor: United Therapeutics
Conditions: Pulmonary Arterial Hypertension
Interventions: Treprostinil Diolamine, Placebo
First posted: 2012-03-22
Last updated: 2020-02-13
Results first posted: 2020-02-13

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Time to First Clinical Worsening Event	From randomization to approximately 4 years	Clinical worsening was assessed continuously from randomization until the subject's last study visit. Clinical worsening events were defined as death (all causes), hospitalizations due to worsening pulmonary arterial hypertension (PAH), initiation of an inhaled or infused prostacyclin (PGI2) for the treatment of worsening PAH, disease progression, or unsatisfactory long-term clinical response. All clinical worsening events reported by the study sites were reviewed by the Sponsor Medical Monitors. Once a clinical worsening event occurred, it was entered in the eCRF and a narrative was submitted for review by the Sponsor's Medical Monitor within 48 hours after the event became known to the Investigator or designee. Subsequently, the narratives for subjects with the reported clinical worsening events were sent to an independent adjudication committee. The independent adjudication committee reviewed and adjudicated all clinical worsening events throughout the study.
Secondary	Change in 6-Minute Walk Distance	From Baseline to Week 24	The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living. A baseline 6MWT was performed prior to initiation of study drug on the day of randomization. 6MWTs were conducted at Weeks 4, 8, 12, 24, and every 12 weeks thereafter. The change between Baseline and Week 24 is reported.
Secondary	Change in Plasma N-Terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 24	From Baseline to Week 24	Plasma NT-proBNP concentration is a useful biomarker for the severity of PAH as it is associated with changes in right heart morphology and function. NT-proBNP sample collection occurred at Baseline (prior to starting study drug), Week 12, Week 24, the first Continued Visit, and every other Continued Visit thereafter (ie, Continued Visits 3, 5, 7, etc). NT-proBNP was also assessed at the Study Drug Termination Visit. The change between Baseline and Week 24 is reported.
Secondary	Change in World Health Organization Functional Class (WHO FC) From Baseline to Week 48	Baseline to Week 48	The WHO FC for PAH was assessed at Baseline prior to starting study drug, at all subsequent scheduled study visits, and every time the 6MWT was performed for purposes of assessing clinical worsening status.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to First Clinical Worsening Event	From randomization to approximately 4 years		weeks	MEAN
SECONDARY	Change in 6-Minute Walk Distance	From Baseline to Week 24		meters	MEAN
SECONDARY	Change in Plasma N-Terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 24	From Baseline to Week 24	Subjects who did not have a valid NT-proBNP measurement at Baseline or Week 24 were excluded from the analysis.	Ratio to baseline	LEAST_SQUARES_MEAN
SECONDARY	Change in World Health Organization Functional Class (WHO FC) From Baseline to Week 48	Baseline to Week 48		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
Time to First Clinical Worsening Event	UT-15C		60.58	Standard Deviation 42.93	weeks
Time to First Clinical Worsening Event	Placebo		49.31	Standard Deviation 46.28	weeks
Change in 6-Minute Walk Distance	UT-15C	Baseline	392.9	Standard Deviation 92.5	meters
Change in 6-Minute Walk Distance	Placebo	Baseline	398.5	Standard Deviation 100.00	meters
Change in 6-Minute Walk Distance	UT-15C	Week 24	395.4	Standard Deviation 120.0	meters
Change in 6-Minute Walk Distance	Placebo	Week 24	372.3	Standard Deviation 163.0	meters
Change in Plasma N-Terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 24	UT-15C		0.7859	Standard Error 1.05470	Ratio to baseline
Change in Plasma N-Terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 24	Placebo		1.1230	Standard Error 1.05439	Ratio to baseline
Change in World Health Organization Functional Class (WHO FC) From Baseline to Week 48	UT-15C	Improved	46		Participants
Change in World Health Organization Functional Class (WHO FC) From Baseline to Week 48	Placebo	Improved	38		Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	UT-15C	346
Overall Study	STARTED	Placebo	344
Overall Study	Clinical Worsening Event	UT-15C	91
Overall Study	Clinical Worsening Event	Placebo	133
Overall Study	Early Discontinuation From Treatment	UT-15C	107
Overall Study	Early Discontinuation From Treatment	Placebo	56
Overall Study	COMPLETED	UT-15C	148
Overall Study	COMPLETED	Placebo	155
Overall Study	NOT COMPLETED	UT-15C	198
Overall Study	NOT COMPLETED	Placebo	189

Source ClinicalTrials.gov

Adverse events468

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	17	346	17
other	Anaemia	Blood and lymphatic system disorders	Placebo	12	344	17
other	Palpitations	Cardiac disorders	UT-15C	47	346	48
other	Palpitations	Cardiac disorders	Placebo	31	344	35
other	Right ventricular failure	Cardiac disorders	UT-15C	22	346	23
other	Right ventricular failure	Cardiac disorders	Placebo	19	344	19
other	Diarrhoea	Gastrointestinal disorders	UT-15C	240	346	277
other	Diarrhoea	Gastrointestinal disorders	Placebo	98	344	106
other	Nausea	Gastrointestinal disorders	UT-15C	139	346	146
other	Nausea	Gastrointestinal disorders	Placebo	78	344	90

1 to 10 of 468Source ClinicalTrials.gov

See all 468 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	UT-15C	17	346
Total, all-cause mortality	Placebo	18	344
Total, other adverse events	UT-15C	342	346
Total, other adverse events	Placebo	328	344
Total, serious adverse events	UT-15C	116	346
Total, serious adverse events	Placebo	110	344

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31765604	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 comparisons2

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

Comparison	Source
UT-15C vs Placebo: deaths from any cause	Trial comparisons
UT-15C 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/NCT01560624

GET https://conductscience.org/api/trials/v1/NCT01560624/events?page=2

API reference For AI assistants