Trial · NCT00325442

FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)

NCT00325442, Phase 3, Completed, United Therapeutics; results first posted 2013-06-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH). Trials, record NCT00325442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00325442

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Trial

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

Title: FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
NCT number: NCT00325442
Status: Completed
Phases: Phase 3
Enrollment: 354 participants, actual
Lead sponsor: United Therapeutics
Conditions: Pulmonary Hypertension
Interventions: Oral treprostinil (UT-15C) sustained release tablets, Placebo
First posted: 2006-05-12
Last updated: 2017-08-02
Results first posted: 2013-06-10

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Six Minute Walk Distance (6MWD)	Baseline and 16 Weeks	Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 16, correlates with the historical 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 six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
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 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).
Secondary	Clinical Worsening Assessment	Baseline and 16 Weeks	Definition of clinical worsening required one of the following: 1. Death (all causes excluding accident) 2. Transplantation or atrial septostomy 3. Clinical deterioration as defined by: 1. Hospitalization as a result of PAH, or 2. ≥ 20% decrease in 6-minute walk distance from Baseline (or too ill to walk) and a decrease in WHO functional class And 3. Initiation of new PAH specific therapy (i.e., ERA, PDE5I, prostacyclin).
Secondary	Dyspnea-Fatigue Index	Baseline and 16 Weeks	The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.
Secondary	World Health Organization Functional Classification for PAH	Week 16	Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope. Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope. Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity.
Secondary	Six Minute Walk Distance (6MWD)	Baseline and 12 weeks	Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical 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 six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Secondary	Six Minute Walk Distance (6MWD)	Baseline and 8 weeks	Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical 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 six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Secondary	Six Minute Walk Distance (6MWD)	Baseline and 4 weeks	Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical 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 six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
Secondary	Change in Symptoms of PAH From Baseline to Week 16	Baseline and 16 weeks	Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 16. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom. The outcome data describes the change in severity values from Baseline to Week 16 for each defined symptom of PAH.

Source ClinicalTrials.gov

Outcomes20

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Six Minute Walk Distance (6MWD)	Baseline and 16 Weeks		meters	MEDIAN
SECONDARY	Borg Dyspnea Score	Baseline and 16 Weeks	One subject in the placebo arm did not have a Baseline Borg score value.	units on a scale	MEAN
SECONDARY	Clinical Worsening Assessment	Baseline and 16 Weeks		participants	NUMBER
SECONDARY	Dyspnea-Fatigue Index	Baseline and 16 Weeks	Five subjects in the placebo arm and three subjects in the active arm did not have a Baseline dypsnea-fatigue index score.	units on a scale	MEAN
SECONDARY	World Health Organization Functional Classification for PAH	Week 16		participants	NUMBER
SECONDARY	Six Minute Walk Distance (6MWD)	Baseline and 12 weeks		meters	MEDIAN
SECONDARY	Six Minute Walk Distance (6MWD)	Baseline and 8 weeks		meters	MEDIAN
SECONDARY	Six Minute Walk Distance (6MWD)	Baseline and 4 weeks		meters	MEDIAN
POST_HOC	Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartiles: Quartile 1 (126-302 Meters)	Baseline and 16 weeks	The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 1 (126 - 302 meters).	meters	MEDIAN
POST_HOC	Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 2 (303 - 362 Meters)	Baseline and 16 weeks	The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 2 (303 - 362 meters).	meters	MEDIAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group123

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

Outcome	Group	Category	Value	Spread	Units
Six Minute Walk Distance (6MWD)	Placebo Arm	6MWD at Baseline	362.5	Inter-Quartile Range 302.0 to 400.0	meters
Six Minute Walk Distance (6MWD)	Active	6MWD at Baseline	362.5	Inter-Quartile Range 304.0 to 397.0	meters
Six Minute Walk Distance (6MWD)	Placebo Arm	6MWD at Week 16	367.0	Inter-Quartile Range 283.0 to 420.5	meters
Six Minute Walk Distance (6MWD)	Active	6MWD at Week 16	381.0	Inter-Quartile Range 323.0 to 420.0	meters
Six Minute Walk Distance (6MWD)	Placebo Arm	Change in 6MWD from Baseline to Week 16	4.8	Inter-Quartile Range -22.0 to 35.5	meters
Six Minute Walk Distance (6MWD)	Active	Change in 6MWD from Baseline to Week 16	14.5	Inter-Quartile Range -10.0 to 47.0	meters
Borg Dyspnea Score	Placebo Arm	Borg dyspnea score at Baseline	4.26	Standard Deviation 2.25	units on a scale
Borg Dyspnea Score	Active	Borg dyspnea score at Baseline	4.22	Standard Deviation 2.24	units on a scale
Borg Dyspnea Score	Placebo Arm	Borg dyspnea score at Week 16	4.64	Standard Deviation 2.62	units on a scale
Borg Dyspnea Score	Active	Borg dyspnea score at Week 16	4.18	Standard Deviation 2.59	units on a scale

1 to 10 of 123Source ClinicalTrials.gov

See all 123 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Arm	176
Overall Study	STARTED	Active	174
Overall Study	COMPLETED	Placebo Arm	167
Overall Study	COMPLETED	Active	153
Overall Study	NOT COMPLETED	Placebo Arm	9
Overall Study	NOT COMPLETED	Active	21

Source ClinicalTrials.gov

Adverse events182

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	Placebo Arm	65	176	69
other	headache	Nervous system disorders	Active	150	174	164
other	nausea	Gastrointestinal disorders	Placebo Arm	60	176	65
other	nausea	Gastrointestinal disorders	Active	112	174	126
other	diarrhea	Gastrointestinal disorders	Placebo Arm	48	176	49
other	diarrhea	Gastrointestinal disorders	Active	106	174	115
other	flushing	Vascular disorders	Placebo Arm	27	176	28
other	flushing	Vascular disorders	Active	85	174	87
other	pain in jaw	Musculoskeletal and connective tissue disorders	Placebo Arm	21	176	22
other	pain in jaw	Musculoskeletal and connective tissue disorders	Active	75	174	77

1 to 10 of 182Source ClinicalTrials.gov

See all 182 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Arm
Total, all-cause mortality	Active
Total, other adverse events	Placebo Arm	157	176
Total, other adverse events	Active	173	174
Total, serious adverse events	Placebo Arm	33	176
Total, serious adverse events	Active	32	174

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22628490	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 comparisons2

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

Comparison	Source
Active vs Placebo Arm: Clinical Worsening Assessment	Trial comparisons
Active vs Placebo Arm: 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/NCT00325442

GET https://conductscience.org/api/trials/v1/NCT00325442/results?page=2

API reference For AI assistants