Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy (FREEDOM-EV)
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| ClinicalTrials.gov Identifier: NCT01560624 |
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Recruitment Status :
Completed
First Posted : March 22, 2012
Results First Posted : February 13, 2020
Last Update Posted : February 13, 2020
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Sponsor:
United Therapeutics
Information provided by (Responsible Party):
United Therapeutics
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Pulmonary Arterial Hypertension |
| Interventions |
Drug: Treprostinil Diolamine Drug: Placebo |
| Enrollment | 690 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | UT-15C | Placebo |
|---|---|---|
 Arm/Group Description |
Treprostinil diolamine extended-release tablets (oral) 0.125 to 12 mg three times daily (TID) Treprostinil Diolamine: Active |
Matching placebo tablets (oral) Placebo: Placebo |
| Period Title: Overall Study | ||
| Started | 346 | 344 |
| Clinical Worsening Event [1] | 91 | 133 |
| Early Discontinuation From Treatment [2] | 107 | 56 |
| Completed [3] | 148 | 155 |
| Not Completed | 198 | 189 |
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[1]
Including death
[2]
Due to progressive disease, AE, withdrawal by subject, protocol violation, lost to follow-up
[3]
Completed the study without clinical worsening or early discontinuation
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Baseline Characteristics
| Arm/Group Title | UT-15C | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Treprostinil diolamine extended-release tablets (oral) 0.125 to 12 mg TID Treprostinil Diolamine: Active |
Matching placebo tablets (oral) Placebo: Placebo |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 346 | 344 | 690 | |
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Baseline Analysis Population Description |
The Intent-to-Treat (ITT) Population was defined as all subjects randomized into the study who received at least 1 dose of study drug. The Safety Population was defined as all subjects in the study that received study drug. ITT subjects with major protocol deviations were excluded from the Per-Protocol population.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 346 participants | 344 participants | 690 participants | |
| <=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
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| Between 18 and 65 years |
292 84.4%
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294 85.5%
|
586 84.9%
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| >=65 years |
54 15.6%
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50 14.5%
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104 15.1%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 346 participants | 344 participants | 690 participants | |
| 45.6 (15.7) | 44.8 (15.4) | 45.2 (15.5) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 346 participants | 344 participants | 690 participants | |
| Female |
275 79.5%
|
269 78.2%
|
544 78.8%
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| Male |
71 20.5%
|
75 21.8%
|
146 21.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 346 participants | 344 participants | 690 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
150 43.4%
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156 45.3%
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306 44.3%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
8 2.3%
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13 3.8%
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21 3.0%
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| White |
187 54.0%
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173 50.3%
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360 52.2%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
1 0.3%
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2 0.6%
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3 0.4%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 346 participants | 344 participants | 690 participants |
| North America |
39 11.3%
|
54 15.7%
|
93 13.5%
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| Southeast Asia |
162 46.8%
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160 46.5%
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322 46.7%
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| Europe |
55 15.9%
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44 12.8%
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99 14.3%
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| South America |
90 26.0%
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86 25.0%
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176 25.5%
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Time since Diagnosis
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 346 participants | 344 participants | 690 participants | |
| 1.34 (2.50) | 1.37 (2.58) | 1.35 (2.54) | ||
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6MWD at Baseline
Mean (Standard Deviation) Unit of measure: Meters |
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| Number Analyzed | 346 participants | 344 participants | 690 participants | |
| 392.9 (92.5) | 398.5 (100.0) | 395.7 (96.3) | ||
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Etiology of PAH
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 346 participants | 344 participants | 690 participants | |
| Idiopathic or Heritable PAH |
219 63.3%
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216 62.8%
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435 63.0%
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| Collagen Vascular Disease |
94 27.2%
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84 24.4%
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178 25.8%
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| HIV Infection |
2 0.6%
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7 2.0%
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9 1.3%
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| Congenital Heart Defect |
20 5.8%
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27 7.8%
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47 6.8%
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| Other |
11 3.2%
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10 2.9%
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21 3.0%
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WHO Functional Class at Baseline
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 346 participants | 344 participants | 690 participants | |
| I |
9 2.6%
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13 3.8%
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22 3.2%
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| II |
205 59.2%
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228 66.3%
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433 62.8%
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| III |
131 37.9%
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103 29.9%
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234 33.9%
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| IV |
1 0.3%
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0 0.0%
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1 0.1%
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[1]
Measure Description: WHO FC I describes patients who do not experience symptoms with exercise or at rest. WHO FC II describes patients who experience symptoms with ordinary activities but not at rest. WHO FC III describes patients who are limited in normal activities but do not experience symptoms at rest. WHO FC IV describes patients who are symptomatic at rest and experience severe symptoms with any activity.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the Study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
Results Point of Contact
| Name/Title: | Louis Holdstock |
| Organization: | United Therapeutics |
| Phone: | 919-425-8866 |
| EMail: | lholdstock@unither.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | United Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01560624 |
| Other Study ID Numbers: |
TDE-PH-310 |
| First Submitted: | March 9, 2012 |
| First Posted: | March 22, 2012 |
| Results First Submitted: | November 20, 2019 |
| Results First Posted: | February 13, 2020 |
| Last Update Posted: | February 13, 2020 |