Trial · NCT00367770

BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

NCT00367770, Phase 4, Completed, Actelion; results first posted 2016-08-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology. Trials, record NCT00367770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00367770

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Trial

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

Title: BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
NCT number: NCT00367770
Status: Completed
Phases: Phase 4
Enrollment: 37 participants, actual
Lead sponsor: Actelion
Conditions: Pulmonary Arterial Hypertension
Interventions: Tracleer®
First posted: 2006-08-23
Last updated: 2016-09-22
Results first posted: 2016-08-15

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change in 6-minute Walk Distance	from baseline to week 24
Primary	Change in Borg Dyspnea Index	from baseline to week 24	Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
Primary	Number of Participants With a Change in WHO Functional Class	from baseline to week 24	Number of participants with a change in WHO functional class from baseline to week 24. A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in 6-minute Walk Distance	from baseline to week 24	The analysis was done in the safety set.	m	MEAN
PRIMARY	Change in Borg Dyspnea Index	from baseline to week 24	The analysis was done in the safety set.	units on a scale	MEAN
PRIMARY	Number of Participants With a Change in WHO Functional Class	from baseline to week 24	The analysis was done in the safety set.	participants	NUMBER

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Change in 6-minute Walk Distance	Overall Study Arm	13.5	Standard Deviation 57.2	m
Change in Borg Dyspnea Index	Overall Study Arm	0.1	Standard Deviation 1.4	units on a scale
Number of Participants With a Change in WHO Functional Class	Overall Study Arm	13		participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Tracleer	37
Overall Study	COMPLETED	Tracleer	35
Overall Study	NOT COMPLETED	Tracleer	2

Source ClinicalTrials.gov

Adverse events25

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	OEDEMA PERIPHERAL	General disorders	Tracleer	7	37
other	CHEST PAIN	General disorders	Tracleer	4	37
other	FATIGUE	General disorders	Tracleer	2	37
other	NASOPHARYNGITIS	Infections and infestations	Tracleer	5	37
other	LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	Tracleer	2	37
other	VIRAL INFECTION	Infections and infestations	Tracleer	2	37
other	NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	Tracleer	2	37
other	PALPITATIONS	Cardiac disorders	Tracleer	2	37
other	DIZZINESS	Nervous system disorders	Tracleer	2	37
other	HEADACHE	Nervous system disorders	Tracleer	2	37

1 to 10 of 25Source ClinicalTrials.gov

See all 25 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tracleer
Total, other adverse events	Tracleer	25	37
Total, serious adverse events	Tracleer	7	37

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.

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/NCT00367770

GET https://conductscience.org/api/trials/v1/NCT00367770/events?page=2

API reference For AI assistants