Trial · NCT00319111
Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
NCT00319111, Phase 3, Completed, Actelion; results first posted 2012-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Trials, record NCT00319111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00319111
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- NCT number
- NCT00319111
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 151 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Hypertension
- Interventions
- bosentan
- First posted
- 2006-04-27
- Last updated
- 2025-02-04
- Results first posted
- 2012-12-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance | Until discontinuation of study drug, up to 3.3 years | Exercise capacity was assessed using the 6MWT. Area used for testing had to be a minimum of 30m in length and 2-3m in width, with 3m gradations. Areas were well ventilated with air temperature controlled. The test was administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6min period. If the test was stopped before 6 minutes, the main reason for stopping the test was recorded. The tester measured the distance walked by patients during the timed 6min period. |
| Primary | Change From Baseline to All Assessed Time Points in Borg Dyspnea Index | Until discontinuation of study drug, up to 3.3 years | Maximal dyspnea during the walk test was assessed by the patient using the Borg dyspnea index. Immediately following each walk test, patients rated perceived maximal breathlessness during the walk test on a 12-point scale (0 \[nothing at all\], 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 \[maximum ever experienced\]). |
| Primary | Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH) | Until discontinuation of study drug, up to 3.3 years | Disease severity was assessed by WHO classification of PH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA. |
| Primary | Time to Clinical Worsening up to End-of-study | Until discontinuation of study drug, up to 3.3 years | An event of clinical worsening was defined as death during the treatment period, a treatment-emergent adverse event that led to permanent discontinuation of study treatment and with outcome death, hospitalization due to worsening pulmonary hypertension, or lung transplantation. Patients are censored at 1 day after the end of treatment or at day of pulmonary endarterectomy if earlier. |
| Secondary | Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication | Until discontinuation of study drug, up to 3.3 years | |
| Secondary | Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation | 28 days after discontinuation of study drug, up to 3.3 years | |
| Secondary | Occurrence of Liver Function Test and Hemoglobin Abnormality | Until discontinuation of study drug, up to 3.3 years | Number of patients with an increase in liver aminotransferases to \>3 times upper limit of normal (ULN) or a decrease in hemoglobin concentration to ≤10 g/dL |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance | Until discontinuation of study drug, up to 3.3 years | Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 137, 128, 121, 106, and 137 respectively | walk distance change from baseline (m) | MEAN |
| PRIMARY | Change From Baseline to All Assessed Time Points in Borg Dyspnea Index | Until discontinuation of study drug, up to 3.3 years | Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 136, 127, 120, 105, and 136 respectively | Scores on a scale | MEAN |
| PRIMARY | Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH) | Until discontinuation of study drug, up to 3.3 years | Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 138, 129, 123, 109, and 139 respectively | participants with improved WHO class | NUMBER |
| PRIMARY | Time to Clinical Worsening up to End-of-study | Until discontinuation of study drug, up to 3.3 years | Study population | participants | NUMBER |
| SECONDARY | Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication | Until discontinuation of study drug, up to 3.3 years | Study population | participants | NUMBER |
| SECONDARY | Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation | 28 days after discontinuation of study drug, up to 3.3 years | Study population | participants | NUMBER |
| SECONDARY | Occurrence of Liver Function Test and Hemoglobin Abnormality | Until discontinuation of study drug, up to 3.3 years | study population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance | Bosentan | month 6 | 8.4 | Standard Deviation 66.4 | walk distance change from baseline (m) |
| Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance | Bosentan | month 12 | 18.2 | Standard Deviation 64.0 | walk distance change from baseline (m) |
| Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance | Bosentan | month 18 | 17.7 | Standard Deviation 63.1 | walk distance change from baseline (m) |
| Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance | Bosentan | month 24 | 20.2 | Standard Deviation 64.8 | walk distance change from baseline (m) |
| Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance | Bosentan | end of the treatment period | 16.9 | Standard Deviation 69.4 | walk distance change from baseline (m) |
| Change From Baseline to All Assessed Time Points in Borg Dyspnea Index | Bosentan | month 6 | -0.5 | Standard Deviation 1.7 | Scores on a scale |
| Change From Baseline to All Assessed Time Points in Borg Dyspnea Index | Bosentan | month 12 | -0.4 | Standard Deviation 1.8 | Scores on a scale |
| Change From Baseline to All Assessed Time Points in Borg Dyspnea Index | Bosentan | month 18 | -0.1 | Standard Deviation 1.9 | Scores on a scale |
| Change From Baseline to All Assessed Time Points in Borg Dyspnea Index | Bosentan | month 24 | -0.1 | Standard Deviation 1.9 | Scores on a scale |
| Change From Baseline to All Assessed Time Points in Borg Dyspnea Index | Bosentan | end of the treatment period | -0.2 | Standard Deviation 2.1 | Scores on a scale |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bosentan | 151 | |
| Overall Study | COMPLETED | Bosentan | 104 | |
| Overall Study | NOT COMPLETED | Bosentan | 47 |
Source ClinicalTrials.gov
Adverse events70
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 | HEPATIC ENZYME INCREASED | Investigations | Bosentan | 3 | 151 | |
| other | LIVER FUNCTION TEST ABNORMAL | Investigations | Bosentan | 3 | 151 | |
| other | ANOREXIA | Metabolism and nutrition disorders | Bosentan | 1 | 151 | |
| other | ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | Bosentan | 1 | 151 | |
| other | DYSPEPSIA | Gastrointestinal disorders | Bosentan | 1 | 151 | |
| other | NASAL MUCOSAL DISORDER | Respiratory, thoracic and mediastinal disorders | Bosentan | 1 | 151 | |
| other | NAUSEA | Gastrointestinal disorders | Bosentan | 1 | 151 | |
| other | PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | Bosentan | 1 | 151 | |
| other | VOMITING | Gastrointestinal disorders | Bosentan | 1 | 151 | |
| serious | Right ventricular failure | Cardiac disorders | Bosentan | 11 | 151 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosentan | ||
| Total, other adverse events | Bosentan | 11 | 151 |
| Total, serious adverse events | Bosentan | 51 | 151 |
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/NCT00319111
GET https://conductscience.org/api/trials/v1/NCT00319111/results?page=2