Trial · NCT00887978

Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension

NCT00887978, Phase 3, Completed, United Therapeutics; results first posted 2013-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension. Trials, record NCT00887978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00887978

On this page

Trial

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

Title: Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
NCT number: NCT00887978
Status: Completed
Phases: Phase 3
Enrollment: 310 participants, actual
Lead sponsor: United Therapeutics
Conditions: Pulmonary Hypertension
Interventions: UT-15C SR, Placebo
First posted: 2009-04-24
Last updated: 2013-01-15
Results first posted: 2013-01-15

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	6-minute Walk Distance (6MWD)	Baseline and 16 weeks	Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). The 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies).
Secondary	Clinical Worsening Assessment	Baseline and 16 Weeks	Definition of clinical worsening included patients who met at least one of the following criteria during the 16 weeks of study: 1. Death (all causes excluding accident) 2. Transplantation 3. Atrial septostomy 4. Hospitalization as a result of right heart failure 5. Greater than or equal to a 20% decrease in 6MWD from Baseline (or too ill to walk) AND addition of an inhaled prostacyclin analogue, ERA, or PDE-5i 6. Initiation of parenteral prostacyclin therapy (i.e., epoprostenol, iloprost, or treprostinil) for the treatment of PAH
Secondary	Borg Dyspnea Score	Baseline and 16 Weeks	The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).
Secondary	World Health Organization (WHO) Functional Class	Baseline and 16 Weeks	Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.
Secondary	Symptoms of PAH	Baseline and 16 Weeks	Symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed by the physician at Baseline and Week 16. Severity grade values (i.e., 0, 1, 2 or 3) for each symptom were provided each subject. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Mean change in symptom severity from Baseline to Week 16 is described.
Secondary	Dyspnea Fatigue Index	Baseline and 16 Weeks	The dyspnea-fatigue index was assessed at Baseline and Week 16. Each of the three components of the dyspnea-fatigue index were rated on a scale 0 to 4, with 0 being the worst condition and 4 being the best condition for each component. The dyspnea-fatigue index is computed by summing the three component scores.
Secondary	N-terminal proBNP (NT-proBNP)	Baseline and 16 Weeks	Serum N-terminal pro-BNP concentration was assessed at Baseline and Week 16.
Secondary	Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)	Baseline and 16 Weeks	Change in CAMPHOR Scores from Baseline to Week 16. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.

Source ClinicalTrials.gov

Outcomes16

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	6-minute Walk Distance (6MWD)	Baseline and 16 weeks	Intention to treat analysis	meters	MEDIAN
SECONDARY	Clinical Worsening Assessment	Baseline and 16 Weeks	Intention to treat analysis	number of clinical worsening events	NUMBER
SECONDARY	Borg Dyspnea Score	Baseline and 16 Weeks	All subjects with a Baseline Borg Score were included in the analysis. One subject in the placebo group did not have a Baseline Borg Score recorded.	score	MEDIAN
SECONDARY	World Health Organization (WHO) Functional Class	Baseline and 16 Weeks	Subjects with a WHO functional class assessment at Week 16	participants	NUMBER
SECONDARY	Symptoms of PAH	Baseline and 16 Weeks	Subjects without Baseline assessments of PAH symptoms were not included in the analysis.	units on a scale	MEAN
SECONDARY	Dyspnea Fatigue Index	Baseline and 16 Weeks	Subjects without a Dyspnea Fatigue Index score at Baseline were not included in the analysis.	units on a scale	MEAN
SECONDARY	N-terminal proBNP (NT-proBNP)	Baseline and 16 Weeks	Subjects who were missing Week 16 samples were not included in the analysis.	pg/mL	MEAN
SECONDARY	Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)	Baseline and 16 Weeks	Subjects in countries where the CAMPHOR has not been validated in the local language were not included in these analyses. Additionally, only subjects with completed questionnaires at Baseline and Week 16 were analyzed.	units on a scale	MEDIAN
POST_HOC	6-minute Walk Distance by PAH Etiology: Idiopathic PAH (IPAH) / Heritable PAH(HPAH)	Baseline and 16 Weeks	Subjects with IPAH/HPAH	meters	MEDIAN
POST_HOC	6-minute Walk Distance by Background PAH Therapy: PDE-5i Only	16 weeks	Subjects receiving only a PDE-5i at Baseline	meters	MEDIAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group62

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

Outcome	Group	Category	Value	Spread	Units
6-minute Walk Distance (6MWD)	UT-15C SR	Week 16 Values	370	Inter-Quartile Range 292 to 419	meters
6-minute Walk Distance (6MWD)	Placebo	Week 16 Values	365	Inter-Quartile Range 300 to 405	meters
6-minute Walk Distance (6MWD)	UT-15C SR	Change from Baseline	15	Inter-Quartile Range -12 to 55	meters
6-minute Walk Distance (6MWD)	Placebo	Change from Baseline	11	Inter-Quartile Range -14 to 39	meters
Clinical Worsening Assessment	UT-15C SR		11		number of clinical worsening events
Clinical Worsening Assessment	Placebo		10		number of clinical worsening events
Borg Dyspnea Score	UT-15C SR	Week 16 Value	3.0	Inter-Quartile Range 2.47	score
Borg Dyspnea Score	Placebo	Week 16 Value	4.0	Inter-Quartile Range 2.05	score
Borg Dyspnea Score	UT-15C SR	Change from Baseline	0	Inter-Quartile Range -1.0 to 1.0	score
Borg Dyspnea Score	Placebo	Change from Baseline	0	Inter-Quartile Range -1.0 to 1.0	score

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	UT-15C SR	157
Overall Study	STARTED	Placebo	153
Overall Study	COMPLETED	UT-15C SR	132
Overall Study	COMPLETED	Placebo	138
Overall Study	NOT COMPLETED	UT-15C SR	25
Overall Study	NOT COMPLETED	Placebo	15

Source ClinicalTrials.gov

Adverse events142

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	Headache	Nervous system disorders	UT-15C SR	112	157	145
other	Headache	Nervous system disorders	Placebo	61	153	69
other	Diarrhea	Gastrointestinal disorders	UT-15C SR	87	157	105
other	Diarrhea	Gastrointestinal disorders	Placebo	38	153	42
other	Nausea	Gastrointestinal disorders	UT-15C SR	73	157	77
other	Nausea	Gastrointestinal disorders	Placebo	34	153	35
other	Flushing	Vascular disorders	UT-15C SR	55	157	64
other	Flushing	Vascular disorders	Placebo	16	153	18
other	Pain in jaw	Musculoskeletal and connective tissue disorders	UT-15C SR	39	157	39
other	Pain in jaw	Musculoskeletal and connective tissue disorders	Placebo	10	153	10

1 to 10 of 142Source ClinicalTrials.gov

See all 142 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	UT-15C SR
Total, all-cause mortality	Placebo
Total, other adverse events	UT-15C SR	157	157
Total, other adverse events	Placebo	136	153
Total, serious adverse events	UT-15C SR	23	157
Total, serious adverse events	Placebo	23	153

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23669822	DERIVED	PubMed
28090293	DERIVED	PubMed
41627369	DERIVED	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 comparisons1

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

Comparison
UT-15C SR vs Placebo: serious adverse events

Source 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/NCT00887978

GET https://conductscience.org/api/trials/v1/NCT00887978/results?page=2

API reference For AI assistants