Trial · NCT02060721
Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
NCT02060721, Phase 2, Completed, Actelion; results first posted 2023-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension. Trials, record NCT02060721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02060721
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
- NCT number
- NCT02060721
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension
- Interventions
- Macitentan
- First posted
- 2014-02-12
- Last updated
- 2025-03-30
- Other registries' IDs
- eudract:2013-003457-25
- Results first posted
- 2023-04-11
- Limitations and caveats
- Study limitations included the open-label (OL), uncontrolled design, and small sample size.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication. |
| Primary | Number of Participants With AEs Leading to Study Drug Discontinuation | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | Number of participants with AEs leading to study drug discontinuation was reported. |
| Primary | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication. |
| Primary | Number of Participants With Hemoglobin Abnormalities | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | Number of participants with hemoglobin abnormalities were reported. It included hemoglobin less than (\<) 80 grams per liter (g/L), hemoglobin \<100 g/L, hemoglobin greater than or equal to (\>=) 80 g/L and \<100 g/L, hemoglobin \<100g/L and a decrease of \>20 g/L from baseline, decrease of \>20 g/L in hemoglobin from baseline, decrease of \>20 g/L and \<=50 g/L in hemoglobin from baseline, and decrease of \>50 g/L in hemoglobin from baseline. |
| Primary | Number of Participants With Liver Tests Abnormalities | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | Number of participants with liver tests abnormalities were reported. It included alanine aminotransferase (ALT) or aspartate aminotransferase (AST): \>=3 x Upper limit of the normal range (ULN), \>=3 and \<5 x ULN, \>=5 ULN, and \>=5 and \<8 x ULN, \>= 8 x ULN, and total bilirubin \>=2 x ULN. |
| Primary | Change From Baseline in Blood Pressure at Month 6 | Baseline and Month 6 | Change from baseline in blood pressure at Month 6 (both systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) was reported. |
| Primary | Change From Baseline in Pulse Rate at Month 6 | Baseline and Month 6 | Change from baseline in pulse rate at Month 6 was reported. |
| Primary | Change From Baseline in Body Weight at Month 6 | Baseline and Month 6 | Change from baseline in body weight at Month 6 was reported. |
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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs Leading to Study Drug Discontinuation | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Hemoglobin Abnormalities | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Liver Tests Abnormalities | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months) | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Blood Pressure at Month 6 | Baseline and Month 6 | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure. | Millimeters of mercury (mmHg) | MEAN |
| PRIMARY | Change From Baseline in Pulse Rate at Month 6 | Baseline and Month 6 | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure. | Beats per minute | MEAN |
| PRIMARY | Change From Baseline in Body Weight at Month 6 | Baseline and Month 6 | OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure. | kilograms (kg) | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Macitentan 10 Milligrams (mg) | 72 | Participants | ||
| Number of Participants With AEs Leading to Study Drug Discontinuation | Macitentan 10 Milligrams (mg) | 9 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | Macitentan 10 Milligrams (mg) | 44 | Participants | ||
| Number of Participants With Hemoglobin Abnormalities | Macitentan 10 Milligrams (mg) | Hemoglobin < 80 g/L | 0 | Participants | |
| Number of Participants With Hemoglobin Abnormalities | Macitentan 10 Milligrams (mg) | Hemoglobin <100 g/L | 7 | Participants | |
| Number of Participants With Hemoglobin Abnormalities | Macitentan 10 Milligrams (mg) | Hemoglobin >= 80 g/L and <100 g/L | 7 | Participants | |
| Number of Participants With Hemoglobin Abnormalities | Macitentan 10 Milligrams (mg) | Hemoglobin <100g/L and a decrease of >20 g/L from baseline | 6 | Participants | |
| Number of Participants With Hemoglobin Abnormalities | Macitentan 10 Milligrams (mg) | Decrease of >20 g/L in hemoglobin from baseline | 32 | Participants | |
| Number of Participants With Hemoglobin Abnormalities | Macitentan 10 Milligrams (mg) | Decrease of >20 g/L and <=50 g/L in hemoglobin from baseline | 31 | Participants | |
| Number of Participants With Hemoglobin Abnormalities | Macitentan 10 Milligrams (mg) | Decrease of >50 g/L in hemoglobin from baseline | 5 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macitentan 10 Milligrams (mg) | 76 | |
| Overall Study | COMPLETED | Macitentan 10 Milligrams (mg) | 38 | |
| Overall Study | NOT COMPLETED | Macitentan 10 Milligrams (mg) | 38 |
Source ClinicalTrials.gov
Adverse events105
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 | Anaemia | Blood and lymphatic system disorders | Macitentan 10 Milligrams (mg) | 10 | 76 | 11 |
| other | Cardiac Failure | Cardiac disorders | Macitentan 10 Milligrams (mg) | 5 | 76 | 5 |
| other | Cataract | Eye disorders | Macitentan 10 Milligrams (mg) | 6 | 76 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Macitentan 10 Milligrams (mg) | 7 | 76 | 11 |
| other | Oedema Peripheral | General disorders | Macitentan 10 Milligrams (mg) | 11 | 76 | 13 |
| other | Pyrexia | General disorders | Macitentan 10 Milligrams (mg) | 4 | 76 | 5 |
| other | Bronchitis | Infections and infestations | Macitentan 10 Milligrams (mg) | 9 | 76 | 14 |
| other | Covid-19 | Infections and infestations | Macitentan 10 Milligrams (mg) | 6 | 76 | 7 |
| other | Nasopharyngitis | Infections and infestations | Macitentan 10 Milligrams (mg) | 9 | 76 | 15 |
| other | Respiratory Tract Infection Viral | Infections and infestations | Macitentan 10 Milligrams (mg) | 4 | 76 | 4 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan 10 Milligrams (mg) | 14 | 76 |
| Total, other adverse events | Macitentan 10 Milligrams (mg) | 67 | 76 |
| Total, serious adverse events | Macitentan 10 Milligrams (mg) | 44 | 76 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39520648 | 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 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/NCT02060721
GET https://conductscience.org/api/trials/v1/NCT02060721/events?page=2