Trial · NCT00147199

Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)

NCT00147199, Phase 3, Completed, United Therapeutics; results first posted 2013-08-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH). Trials, record NCT00147199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00147199

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Trial

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

Title: Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)
NCT number: NCT00147199
Status: Completed
Phases: Phase 3
Enrollment: 235 participants, actual
Lead sponsor: United Therapeutics
Conditions: Pulmonary Hypertension
Interventions: Inhaled treprostinil, Placebo inhalation solution
First posted: 2005-09-07
Last updated: 2024-01-02
Results first posted: 2013-08-12

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Peak 6-minute Walk Distance	12 weeks	Change in peak 6-minute walk distance from baseline to Week 12. Peak 6MWD was defined as a 6-minute walk test (6MWT) within 10 to 60 minutes after study drug inhalation
Secondary	Clinical Worsening Events	12 weeks	Clinical worsening was defined as the first incidence of clinical worsening from randomization to the first occurrence of death, transplantation, hospitalization for PAH, or initiation of additional approved PAH therapy.
Secondary	Borg Dyspnea Score	12 weeks	The Borg dyspnea score is a patient reported number between 0 (no perceived shortness of breath) and 10 (maximum perceived shortness of breath), obtained at the completion of each 6MWT.
Secondary	New York Heart Association (NYHA) Functional Classification	12 weeks	Change in NYHA functional class at Week 12. NYHA classifications: 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. They are comfortable at rest. 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. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV - Patients with pulmonary hypertension in the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.
Secondary	Trough 6MWD at Week 12	12 Weeks	Change in 6MWD from Baseline to trough 6MWD at Week 12. Trough was defined as a 6MWT conducted at least 4 hours following study drug inhalation.
Secondary	Peak 6MWD at Week 6	6 weeks	Change in peak 6MWD between Baseline and Week 6.
Secondary	Quality of Life (Minnesota Living With Heart Failure)	12 weeks	Quality of life as measured by the Minnesota Living With Heart Failure (MLWHF) questionnaire was evaluated at baseline and at Week 12. The MLWHF questionnaire consists of 21 questions assessing how the patient's heart failure has prevented them from living the way they wanted during the defined time period. Each question was graded by the patient with a numeric value between 0 (No/none) and 5 (very much). These scores were then summed across the 21 questions for a Global Score. Global scores ranged from 0 to 105. These questions were further grouped into Physical (8 of the questions) and Emotional (5 of the questions) dimensions to further characterize the effect of heart failure on the patient's life. Physical scores ranged from 0 to 40, and emotional scores ranged from 0 to 25. For all 3 categories, the lower the score, the better the outcome. Values presented as change from Baseline.
Secondary	Change in Signs and Symptoms of PAH	12 weeks	Signs and symptoms of PAH (Loud P2 sound, Ascites, Right ventricular S3 sound, Dyspnea, Right ventricular S4 sound, Orthopnea, Right ventricular heave, Dizziness, Murmur of tricuspid insufficiency, Syncope, Murmur of pulmonic insufficiency, Chest pain, Hepatomegaly, Palpitations, Jugular venous distension at 45 degrees, Fatigue, Edema) were assessed at Baseline and Week 12. The status of each sign and symptom ("absent" or "present") was assessed at each visit. To assess overall change from baseline in signs and symptoms, a "1" was assigned for each sign and symptom that was "present" at the Week 12 but was "absent" at baseline, a "-1" was assigned for each sign and symptom that was "absent" at Week 12 but was "present" at baseline, and a "0" was assigned for no change. An overall change score at each post-baseline assessment was then calculated by summing these values for all signs and symptoms. The overall change score had the potential to range from -17 to 17.
Secondary	N-terminal Pro-B-Type Natriuretic Peptide (NT Pro-BNP)	12 weeks	Change in NT pro-BNP from Baseline to Week 12. Plasma samples were collected from patients at Baseline and Week 12 in order to measure any change over time in circulating plasma levels of this biomarker.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Peak 6-minute Walk Distance	12 weeks	Intention to treat analysis	meters	MEDIAN
SECONDARY	Clinical Worsening Events	12 weeks	Intention to treat population	clinical worsening events	NUMBER
SECONDARY	Borg Dyspnea Score	12 weeks	Intention to treat population. A Week 12 observation was not present for one subject and that data point is not included in the analysis.	score	MEAN
SECONDARY	New York Heart Association (NYHA) Functional Classification	12 weeks	Intention to treat population	participants	NUMBER
SECONDARY	Trough 6MWD at Week 12	12 Weeks	Intention to treat population	meters	MEDIAN
SECONDARY	Peak 6MWD at Week 6	6 weeks	Intention to treat	meters	MEDIAN
SECONDARY	Quality of Life (Minnesota Living With Heart Failure)	12 weeks	Intention to treat population.	units on a scale	MEDIAN
SECONDARY	Change in Signs and Symptoms of PAH	12 weeks	Intention to treat population.	units on a scale	MEDIAN
SECONDARY	N-terminal Pro-B-Type Natriuretic Peptide (NT Pro-BNP)	12 weeks	Per protocol	pg/mL	MEDIAN

Source ClinicalTrials.gov

Results by group36

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

Outcome	Group	Category	Value	Spread	Units
Peak 6-minute Walk Distance	Inhaled Treprostinil	Week 12	366.0	Inter-Quartile Range 300.0 to 423.0	meters
Peak 6-minute Walk Distance	Placebo	Week 12	360.0	Inter-Quartile Range 296.0 to 414.9	meters
Peak 6-minute Walk Distance	Inhaled Treprostinil	Change from Baseline	21.6	Inter-Quartile Range -8.0 to 54.0	meters
Peak 6-minute Walk Distance	Placebo	Change from Baseline	3.0	Inter-Quartile Range -26.0 to 31.5	meters
Clinical Worsening Events	Inhaled Treprostinil		4		clinical worsening events
Clinical Worsening Events	Placebo		6		clinical worsening events
Borg Dyspnea Score	Inhaled Treprostinil	Week 12	3.68	Standard Deviation 2.26	score
Borg Dyspnea Score	Placebo	Week 12	3.91	Standard Deviation 2.33	score
Borg Dyspnea Score	Inhaled Treprostinil	Change from Baseline	0.0	Standard Deviation 2.07	score
Borg Dyspnea Score	Placebo	Change from Baseline	0.0	Standard Deviation 1.72	score

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Inhaled Treprostinil	115
Overall Study	STARTED	Placebo	120
Overall Study	COMPLETED	Inhaled Treprostinil	102
Overall Study	COMPLETED	Placebo	110
Overall Study	NOT COMPLETED	Inhaled Treprostinil	13
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events84

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
other	cough	Respiratory, thoracic and mediastinal disorders	Inhaled Treprostinil	62	115
other	cough	Respiratory, thoracic and mediastinal disorders	Placebo	35	120
other	headache	Nervous system disorders	Inhaled Treprostinil	47	115
other	headache	Nervous system disorders	Placebo	27	120
other	dizziness	Nervous system disorders	Inhaled Treprostinil	20	115
other	dizziness	Nervous system disorders	Placebo	18	120
other	nausea	Gastrointestinal disorders	Inhaled Treprostinil	22	115
other	nausea	Gastrointestinal disorders	Placebo	13	120
other	throat irritation	Respiratory, thoracic and mediastinal disorders	Inhaled Treprostinil	16	115
other	throat irritation	Respiratory, thoracic and mediastinal disorders	Placebo	10	120

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Inhaled Treprostinil
Total, all-cause mortality	Placebo
Total, other adverse events	Inhaled Treprostinil	101	115
Total, other adverse events	Placebo	100	120
Total, serious adverse events	Inhaled Treprostinil	9	115
Total, serious adverse events	Placebo	13	120

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20430262	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 comparisons1

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

Comparison
Inhaled Treprostinil 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.

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GET https://conductscience.org/api/trials/v1/NCT00147199/results?page=2

API reference For AI assistants