Trial · NCT01027949
An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension
NCT01027949, Phase 3, Completed, United Therapeutics; results first posted 2021-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension. Trials, record NCT01027949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01027949
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension
- NCT number
- NCT01027949
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 894 participants, actual
- Lead sponsor
- United Therapeutics
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Oral Treprostinil
- First posted
- 2009-12-09
- Last updated
- 2021-05-10
- Results first posted
- 2021-05-10
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Exercise Capacity at Month 12 | From First Visit (Visit 1) to Month 12 | Assess the effect of continued therapy with oral treprostinil on exercise capacity as assessed by the change from Baseline in 6-Minute Walk Test (6MWT) after 1 year of treatment. The 6MWT is the clinical standard for assessing subject functional status in the treatment of PAH and has been considered an objective measure of subject functional status by the American Thoracic Society. The distance a subject can walk in 6 minutes is recorded in meters. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Exercise Capacity at Month 12 | From First Visit (Visit 1) to Month 12 | All subjects enrolled in the study with Baseline and matched follow-up 6MWTs. | meters | MEDIAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Exercise Capacity at Month 12 | Oral Treprostinil | 22.0 | Full Range -345.0 to 282.0 | meters |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Treprostinil | 894 | |
| Overall Study | COMPLETED | Oral Treprostinil | 208 | |
| Overall Study | NOT COMPLETED | Oral Treprostinil | 686 |
Source ClinicalTrials.gov
Adverse events460
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 | Flushing | Vascular disorders | Oral Treprostinil | 416 | 894 | 499 |
| other | Hypotension | Vascular disorders | Oral Treprostinil | 79 | 894 | 91 |
| other | Fatigue | General disorders | Oral Treprostinil | 201 | 894 | 228 |
| other | Oedema peripheral | General disorders | Oral Treprostinil | 192 | 894 | 240 |
| other | Chest pain | General disorders | Oral Treprostinil | 135 | 894 | 180 |
| other | Pain | General disorders | Oral Treprostinil | 97 | 894 | 102 |
| other | Pyrexia | General disorders | Oral Treprostinil | 83 | 894 | 100 |
| other | Chest discomfort | General disorders | Oral Treprostinil | 57 | 894 | 70 |
| other | Asthenia | General disorders | Oral Treprostinil | 51 | 894 | 64 |
| other | Oedema | General disorders | Oral Treprostinil | 43 | 894 | 44 |
1 to 10 of 460Source ClinicalTrials.gov
See all 460 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Treprostinil | 174 | 894 |
| Total, other adverse events | Oral Treprostinil | 890 | 894 |
| Total, serious adverse events | Oral Treprostinil | 547 | 894 |
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 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.
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/NCT01027949
GET https://conductscience.org/api/trials/v1/NCT01027949/events?page=2