Trial · NCT02021292
Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
NCT02021292, Phase 2, Completed, Actelion; results first posted 2018-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension. Trials, record NCT02021292. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02021292
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
- NCT number
- NCT02021292
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension
- Interventions
- Macitentan, Placebo
- First posted
- 2013-12-27
- Last updated
- 2025-03-30
- Results first posted
- 2018-01-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. | From baseline to Week 16 | The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest. |
| Secondary | Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD). | From baseline to Week 24 | The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. |
| Secondary | Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT). | From baseline to Week 24 | This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 24 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement. |
| Secondary | Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24 | From baseline to Week 24 | WHO functional classes are defined as follows: 1) class I: no symptoms with exercise or at rest. No limitation of activity. 2) class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). 3) class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. 4) class IV: symptoms at rest (such as dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms (e.g. may faint especially while bending over with their heads lowered). Patients in class IV manifest signs of right heart failure. Shifting to a higher class (e.g. from class III to class IV) represents a 'worsening' while shifting to a lower class (e.g. from class III to class II) means an 'improvement'. |
Source ClinicalTrials.gov
Outcomes8
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 Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. | From baseline to Week 16 | Full analysis set included all subjects assigned to a study treatment. | percent of baseline PVR | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD). | From baseline to Week 24 | Full analysis set | meter | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT). | From baseline to Week 24 | Full analysis set | Score on a scale | MEAN |
| SECONDARY | Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24 | From baseline to Week 24 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Including Subjects With Corrected Hemodynamic Values | From baseline to Week 16 | Full analysis set for this post-hoc analysis included all subjects assigned to a study treatment with SDV values. | Percent of baseline PVR | GEOMETRIC_MEAN |
| POST_HOC | Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Excluding Subjects With Corrected Hemodynamic Values | From baseline to Week 16 | Full analysis set excluding subjects with corrected hemodynamic values. | Percent of baseline PVR | GEOMETRIC_MEAN |
| POST_HOC | Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Excluding Subjects With Implausible Hemodynamic Findings | From baseline to Week 16 | Full analysis set excluding subjects with implausible hemodynamic findings. | Percent of baseline PVR | GEOMETRIC_MEAN |
| POST_HOC | Post-hoc Analysis of Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD) Excluding Subjects With Implausible Hemodynamic Findings | From baseline to Week 24 | Full analysis set excluding subjects with implausible hemodynamic findings. | meter | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group46
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 Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. | Macitentan | 73.0 | 95% Confidence Interval 63.6 to 83.8 | percent of baseline PVR | |
| Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. | Placebo | 87.2 | 95% Confidence Interval 78.5 to 96.7 | percent of baseline PVR | |
| Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD). | Macitentan | 6MWD (m) at baseline | 353.0 | Standard Deviation 87.90 | meter |
| Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD). | Placebo | 6MWD (m) at baseline | 351.2 | Standard Deviation 73.79 | meter |
| Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD). | Macitentan | 6MWD (m) at Week 24 | 388.0 | Standard Deviation 83.31 | meter |
| Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD). | Placebo | 6MWD (m) at Week 24 | 352.2 | Standard Deviation 121.29 | meter |
| Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD). | Macitentan | Change in 6MWD (m) from baseline to Week 24 | 35.0 | Standard Deviation 52.52 | meter |
| Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD). | Placebo | Change in 6MWD (m) from baseline to Week 24 | 1.0 | Standard Deviation 83.24 | meter |
| Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT). | Macitentan | Borg dyspnea index score at baseline | 4.2 | Standard Deviation 2.52 | Score on a scale |
| Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT). | Placebo | Borg dyspnea index score at baseline | 4.2 | Standard Deviation 2.14 | Score on a scale |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macitentan | 40 | |
| Overall Study | STARTED | Placebo | 40 | |
| Overall Study | COMPLETED | Macitentan | 40 | |
| Overall Study | COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | Macitentan | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
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 | Alanine aminotransferase increased | Investigations | Macitentan | 0 | 40 | 0 |
| other | Alanine aminotransferase increased | Investigations | Placebo | 3 | 40 | 4 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Macitentan | 1 | 40 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 3 | 40 | 3 |
| other | Aspartate aminotransferase increased | Investigations | Macitentan | 0 | 40 | 0 |
| other | Aspartate aminotransferase increased | Investigations | Placebo | 3 | 40 | 4 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Macitentan | 0 | 40 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 2 | 40 | 2 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Macitentan | 2 | 40 | 3 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 40 | 0 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan | 0 | 40 |
| Total, all-cause mortality | Placebo | 2 | 40 |
| Total, other adverse events | Macitentan | 22 | 40 |
| Total, other adverse events | Placebo | 19 | 40 |
| Total, serious adverse events | Macitentan | 3 | 40 |
| Total, serious adverse events | Placebo | 7 | 40 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Macitentan vs Placebo: deaths from any cause | Trial comparisons |
| Macitentan vs Placebo: 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.
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/NCT02021292
GET https://conductscience.org/api/trials/v1/NCT02021292/results?page=2