A Phase 3 interventional study of Macitentan and Placebo in Chronic Thromboembolic Pulmonary Hypertension, sponsored by Actelion. Terminated at 168 sites in 33 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Actelion · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).
CTEPH is one of the leading causes of severe pulmonary hypertension (PH), classified within World Health Organization (WHO) group 4 PH. It is a rare, progressive pulmonary vascular disease that if left untreated, leads to progressively increasing pulmonary vascular resistance (PVR) and eventually right ventricle failure and death. Histopathologic findings including endothelial cell dysfunction and distal pulmonary arterial remodeling are shared between PAH and CTEPH, and PH-specific therapies (that is, riociguat) have shown efficacy in inoperable and persistent/recurrent CTEPH. The endothelin receptor antagonist macitentan offers a different mode of action and addresses an important unmet medical need for an alternative treatment option in this indication. This study will assess the effect of macitentan 75 mg on exercise capacity in CTEPH. The total duration of the study is approximately 6 years. The study comprises of a screening period (at least 14 days and up to 60 days), a double-blind (DB) treatment period (28 weeks [minimum duration] up to 3.5 years), an open-label (OL) extension period (starts at end-of-DB-treatment [EODBT] and will end for all participants 104 weeks after the last participant has completed DB Week 28). The DB period consists of an 8-week up-titration phase and a maintenance phase. The maintenance phase is divided into a 28-week fixed duration part, at the end of which primary endpoint is assessed, and a variable duration part. The duration of the DB period for an individual participant depends on the timepoint of entry into the study and whether a CEC-confirmed clinical worsening event occurred. Participants who discontinue DB study intervention during the 28-week fixed duration part will be followed until Week 28 in a post-treatment observation period (PTOP).
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Exclusion Criteria:
Participant will receive macitentan at a dose of 10 milligram (mg) once daily (OD) for 4 weeks, followed by a dose of macitentan 37.5 mg for another 4 weeks and continue with the target dose of macitentan 75 mg. Participants who have reached the target dose of 75 mg, completed the Double-blind (DB) period up to Week 28 (either on treatment or in Post-treatment observation period \[PTOP\]) at minimum, may be eligible for transitioning into the Open label (OL) extension period once all participants have completed the DB part of the study, or earlier if they experienced a Clinical event committee (CEC) confirmed clinical worsening event.
Drug: Macitentan
Participants will receive placebo tablets matching the macitentan 10 mg, macitentan 37.5mg and macitentan 75 mg tablets, respectively. Participants who completed the DB period as per protocol either on treatment or in PTOP are eligible for transitioning to the OL extension period and will receive macitentan 75 mg after an 8-week double-dummy uptitration (macitentan 10 mg for 4 weeks, followed by 37.5 mg for another 4 weeks).
Drug: Macitentan · Drug: Placebo
Participants will receive Macitentan film-coated tablets orally od.
Also known as: ACT-064992,, Opsumit
Participant will receive matching placebo tablets orally od.
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 28
Change from baseline in 6MWD as measured by 6-minute walk test (6MWT) at Week 28 was reported. The purpose of the 6MWT was to quantify exercise tolerance and capacity. This standardized test measured the distance an individual was able to walk over a total of six minutes on a hard, flat surface with no obstacles. The goal was for the individual to walk as far as possible in 6 minutes.
Time frame: Baseline (Day 1), Week 28
Time to First Clinical Event Committee (CEC) Confirmed Clinical Worsening up to End-of Double-blind-treatment (EODBT) Period
Time (months) to first CEC-confirmed clinical worsening up to EODBT were reported. Clinical worsening was defined as the occurrence of at least one of the following events: 1) All-cause death; 2) Heart and/or lung transplantation; 3) Unplanned pulmonary hypertension (PH)-related hospitalization; 4) PH-related deterioration from baseline identified by at least one of the following: a) Persistent increase in World Health Organization functional class (WHO FC) that could not be explained by another cause (for example, viral infection); b) Persistent deterioration by at least 15 percent (%) in exercise capacity; as measured by the 6MWD; c) New or worsened signs or symptoms of right heart failure; 5) Rescue pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA) procedure due to worsening of PH.
Time frame: From Baseline (Day 1) up to EODBT: median 24.5 weeks (min 3.9 weeks; max 160.4 weeks) for macitentan, median 44 weeks (min 4 weeks; max 147.9 weeks) for placebo
Number of Participants With Improvement in World Health Organization Functional Class (WHO FC) From Baseline to Week 28
Number of participants with improvement in WHO FC from baseline to Week 28 were reported. Improvement (decrease) in WHO FC from baseline to Week 28 was calculated for each participant. WHO FC test was used to assess disease severity. Four functional classes (FC) were defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). For the analysis purpose, these WHO FC class values were transformed to a scale with scores ranged from 1 to 4; where a score of 1 corresponded to WHO FC Class I and a score of 4 corresponded to WHO FC Class IV. The higher scores indicate greater symptom severity or worse impact. Improvement was considered when a participant changed from a higher class to a lower class.
Time frame: From Baseline (Day 1) up to Week 28
Change From Baseline to Week 28 in Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT) - Cardiopulmonary Symptom Domain Score
The cardiopulmonary symptoms domain consisted of 6 items: shortness of breath, fatigue, lack of energy, swelling in ankles or legs, swelling in stomach area and cough and were reported on a 5-point Likert scale from 0 (no symptom at all) to 4 (very severe symptoms), with higher score indicating more symptom. The symptoms part of the PAH-SYMPACT was administered daily over a 7-day period. The recall period of symptom items was the last 24 hours. The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items, ranged from 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms. A higher score indicated more severe symptoms experienced.
Time frame: From Baseline (Day 1) up to Week 28
Change From Baseline to Week 28 in PAH-SYMPACT - Cardiovascular Symptom Domain Score
The cardiovascular symptoms domain consisted of 5 items: heart palpitations (fluttering), rapid heartbeat, chest pain, chest tightness, and lightheadedness and were reported on a 5-point Likert scale ranged from 0 (no symptoms at al) to 4 (very severe symptoms), with high score indicating more symptom. The symptoms part of PAH-SYMPACT was administered daily over a 7-day period. The recall period of symptom items was the last 24 hours. An average Cardiovascular Symptoms domain score was determined based on the daily scores of the 5 items. The mean individual symptom item score was determined for each of the 5 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items, ranged from 0=no cardiovascular symptoms to 4=severe cardiovascular symptoms. Higher score indicated more severe symptoms experienced.
Time frame: From Baseline (Day 1) up to Week 28
Change From Baseline to Week 28 in Euro Quality of Life-5-Dimension-5-Level (EQ-5D-5L) Utility Score and Visual Analog Scale (VAS) Score
The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L consisted of 2 parts: EQ-5D-5L utility score (descriptive system) and VAS score. EQ-5D-5L descriptive system consisted of 5-item questionnaire that assessed 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each questionnaire had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 questionnaires were used to compute a single utility score which ranged from 0 to 1, where higher score indicated better health state and lower score indicated worse health state. EQ-5D-5L VAS rated current health state on a vertical scale with a score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), higher scores indicated a better health state.
Time frame: From Baseline (Day 1) up to Week 28
Change From Baseline to Week 28 in Accelerometer-assessed Proportion of Time Spent in Moderate to Vigorous Physical Activity
Change from baseline to Week 28 in accelerometer-assessed proportion of time spent in moderate to vigorous physical activity were assessed. Daily life physical activity of participant was assessed using accelerometer which was provided to the participant at screening and was worn daily during waking hours up to Week 28. For each scheduled visit, the 14 days prior to the visit were considered as the assessment period for physical activity. To be considered evaluable for a given timepoint, actigraphy variables should have been measured for at least 7 complete days (consecutive or not). A complete day is defined as a record of at least 7 waking hours of data. Proportion of time spent in moderate to vigorous physical activity was the estimated number of minutes spent in moderate or higher physical activity as calculated using the Staudenmayer '15 technique as proportion of the total minutes of algorithmically detected wear time and excluding the minutes that fall within a sleep period.
Time frame: From Baseline (Day 1) up to Week 28
| Milestone | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Open Label (OL) Period: DB Macitentan | OL Period: DB Placebo |
|---|---|---|---|---|
| Started | 64 | 63 | 0 | 0 |
| Completed | 1 | 1 | 0 | 0 |
| Not completed | 63 | 62 | 0 | 0 |
| Withdrew: Death | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 8 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 5 | 4 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 41 | 52 | 0 | 0 |
| Withdrew: Other | 8 | 5 | 0 | 0 |
| Milestone | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Open Label (OL) Period: DB Macitentan | OL Period: DB Placebo |
|---|---|---|---|---|
| Started | 0 | 0 | 1 | 6 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 1 | 6 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 1 | 5 |
| Withdrew: Other | 0 | 0 | 0 | 1 |
Change from baseline in 6MWD as measured by 6-minute walk test (6MWT) at Week 28 was reported. The purpose of the 6MWT was to quantify exercise tolerance and capacity. This standardized test measured the distance an individual was able to walk over a total of six minutes on a hard, flat surface with no obstacles. The goal was for the individual to walk as far as possible in 6 minutes.
| Meters | Double Blind (DB) Period: Macitentan | DB Period: Placebo |
|---|---|---|
| Change From Baseline in 6-minute Walk Distance (6MWD) at Week 28 | 9.7 ± 5.81 | 25.8 ± 5.78 |
Time (months) to first CEC-confirmed clinical worsening up to EODBT were reported. Clinical worsening was defined as the occurrence of at least one of the following events: 1) All-cause death; 2) Heart and/or lung transplantation; 3) Unplanned pulmonary hypertension (PH)-related hospitalization; 4) PH-related deterioration from baseline identified by at least one of the following: a) Persistent increase in World Health Organization functional class (WHO FC) that could not be explained by another cause (for example, viral infection); b) Persistent deterioration by at least 15 percent (%) in exercise capacity; as measured by the 6MWD; c) New or worsened signs or symptoms of right heart failure; 5) Rescue pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA) procedure due to worsening of PH.
| Months | Double Blind (DB) Period: Macitentan | DB Period: Placebo |
|---|---|---|
| Time to First Clinical Event Committee (CEC) Confirmed Clinical Worsening up to End-of Double-blind-treatment (EODBT) Period | NA (19.0 to NA) | NA (NA to NA) |
Number of participants with improvement in WHO FC from baseline to Week 28 were reported. Improvement (decrease) in WHO FC from baseline to Week 28 was calculated for each participant. WHO FC test was used to assess disease severity. Four functional classes (FC) were defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). For the analysis purpose, these WHO FC class values were transformed to a scale with scores ranged from 1 to 4; where a score of 1 corresponded to WHO FC Class I and a score of 4 corresponded to WHO FC Class IV. The higher scores indicate greater symptom severity or worse impact. Improvement was considered when a participant changed from a higher class to a lower class.
| Participants | Double Blind (DB) Period: Macitentan | DB Period: Placebo |
|---|---|---|
| Number of Participants With Improvement in World Health Organization Functional Class (WHO FC) From Baseline to Week 28 | 7 | 6 |
The cardiopulmonary symptoms domain consisted of 6 items: shortness of breath, fatigue, lack of energy, swelling in ankles or legs, swelling in stomach area and cough and were reported on a 5-point Likert scale from 0 (no symptom at all) to 4 (very severe symptoms), with higher score indicating more symptom. The symptoms part of the PAH-SYMPACT was administered daily over a 7-day period. The recall period of symptom items was the last 24 hours. The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items, ranged from 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms. A higher score indicated more severe symptoms experienced.
| score on a scale | Double Blind (DB) Period: Macitentan | DB Period: Placebo |
|---|---|---|
| Change From Baseline to Week 28 in Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT) - Cardiopulmonary Symptom Domain Score | -0.089 ± 0.5856 | -0.060 ± 0.3767 |
The cardiovascular symptoms domain consisted of 5 items: heart palpitations (fluttering), rapid heartbeat, chest pain, chest tightness, and lightheadedness and were reported on a 5-point Likert scale ranged from 0 (no symptoms at al) to 4 (very severe symptoms), with high score indicating more symptom. The symptoms part of PAH-SYMPACT was administered daily over a 7-day period. The recall period of symptom items was the last 24 hours. An average Cardiovascular Symptoms domain score was determined based on the daily scores of the 5 items. The mean individual symptom item score was determined for each of the 5 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items, ranged from 0=no cardiovascular symptoms to 4=severe cardiovascular symptoms. Higher score indicated more severe symptoms experienced.
| Score on a scale | Double Blind (DB) Period: Macitentan | DB Period: Placebo |
|---|---|---|
| Change From Baseline to Week 28 in PAH-SYMPACT - Cardiovascular Symptom Domain Score | -0.141 ± 0.4530 | -0.101 ± 0.2818 |
The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L consisted of 2 parts: EQ-5D-5L utility score (descriptive system) and VAS score. EQ-5D-5L descriptive system consisted of 5-item questionnaire that assessed 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each questionnaire had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 questionnaires were used to compute a single utility score which ranged from 0 to 1, where higher score indicated better health state and lower score indicated worse health state. EQ-5D-5L VAS rated current health state on a vertical scale with a score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), higher scores indicated a better health state.
| Score on a scale | Double Blind (DB) Period: Macitentan | DB Period: Placebo |
|---|---|---|
| Utility score | 0.0472 ± 0.26700 | 0.0050 ± 0.15010 |
| VAS score | 5.0 ± 17.65 | 1.6 ± 11.97 |
Change from baseline to Week 28 in accelerometer-assessed proportion of time spent in moderate to vigorous physical activity were assessed. Daily life physical activity of participant was assessed using accelerometer which was provided to the participant at screening and was worn daily during waking hours up to Week 28. For each scheduled visit, the 14 days prior to the visit were considered as the assessment period for physical activity. To be considered evaluable for a given timepoint, actigraphy variables should have been measured for at least 7 complete days (consecutive or not). A complete day is defined as a record of at least 7 waking hours of data. Proportion of time spent in moderate to vigorous physical activity was the estimated number of minutes spent in moderate or higher physical activity as calculated using the Staudenmayer '15 technique as proportion of the total minutes of algorithmically detected wear time and excluding the minutes that fall within a sleep period.
| Percent of minutes per day | Double Blind (DB) Period: Macitentan | DB Period: Placebo |
|---|---|---|
| Change From Baseline to Week 28 in Accelerometer-assessed Proportion of Time Spent in Moderate to Vigorous Physical Activity | 0.821 ± 3.9249 | -0.833 ± 4.5160 |
Collected over DB period:DB Day 1 to 30 days post EODBT (median exposure[ME]:24.5 weeks[wks], [min 3.9 wks; max 160.4 wks] on macitentan, ME:44 wks [min 4 wks; max 147.9 wks] on placebo); OL period: OL Day 1 to study termination (ME:72 wks [min 8.1 wks; max 84.6 wks]).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Double Blind (DB) Period: Macitentan | 1/64 (1.6%) | 17/64 (26.6%) | 47/64 (73.4%) |
| DB Period: Placebo | 0/63 (0%) | 14/63 (22.2%) | 38/63 (60.3%) |
| Open Label (OL) Period: DB Macitentan | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| OL Period: DB Placebo | 0/6 (0%) | 4/6 (66.7%) | 5/6 (83.3%) |
| Event | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Open Label (OL) Period: DB Macitentan | OL Period: DB Placebo |
|---|---|---|---|---|
| Pulmonary HypertensionRespiratory, thoracic and mediastinal disorders | 0/64 | 4/63 | 0/1 | 2/6 |
| Right Ventricular FailureCardiac disorders | 1/64 | 0/63 | 0/1 | 1/6 |
| Organising PneumoniaRespiratory, thoracic and mediastinal disorders | 0/64 | 0/63 | 0/1 | 1/6 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 0/64 | 2/63 | 0/1 | 0/6 |
| Atrial TachycardiaCardiac disorders | 0/64 | 1/63 | 0/1 | 0/6 |
| Sinus Node DysfunctionCardiac disorders | 0/64 | 1/63 | 0/1 | 0/6 |
| Vertigo PositionalEar and labyrinth disorders | 0/64 | 1/63 | 0/1 | 0/6 |
| CataractEye disorders | 0/64 | 1/63 | 0/1 | 0/6 |
| Diverticulum Intestinal HaemorrhagicGastrointestinal disorders | 0/64 | 1/63 | 0/1 | 0/6 |
| Postoperative HypertensionInjury, poisoning and procedural complications | 0/64 | 1/63 | 0/1 | 0/6 |
| Event | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Open Label (OL) Period: DB Macitentan | OL Period: DB Placebo |
|---|---|---|---|---|
| Ligament SprainInjury, poisoning and procedural complications | 1/64 | 2/63 | 1/1 | 0/6 |
| Oedema PeripheralGeneral disorders | 18/64 | 5/63 | 0/1 | 1/6 |
| Covid-19Infections and infestations | 15/64 | 14/63 | 0/1 | 1/6 |
| AnaemiaBlood and lymphatic system disorders | 5/64 | 2/63 | 0/1 | 1/6 |
| StomatitisGastrointestinal disorders | 1/64 | 0/63 | 0/1 | 1/6 |
| SwellingGeneral disorders | 0/64 | 0/63 | 0/1 | 1/6 |
| NasopharyngitisInfections and infestations | 3/64 | 8/63 | 0/1 | 1/6 |
| Haemoglobin DecreasedInvestigations | 7/64 | 0/63 | 0/1 | 1/6 |
| Iron DeficiencyMetabolism and nutrition disorders | 2/64 | 1/63 | 0/1 | 1/6 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/64 | 3/63 | 0/1 | 1/6 |
| Age, Customized(Participants) | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Total |
|---|---|---|---|
| Adults (18-64 years) | 23 | 33 | 56 |
| From 65 to 75 years | 32 | 26 | 58 |
| Over 75 years | 9 | 4 | 13 |
| Sex: Female, Male(Participants) | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Total |
|---|---|---|---|
| Female | 37 | 42 | 79 |
| Male | 27 | 21 | 48 |
| Ethnicity (NIH/OMB)(Participants) | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 7 |
| Not Hispanic or Latino | 59 | 58 | 117 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 18 | 26 | 44 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 42 | 34 | 76 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 4 | 0 | 4 |
| Region of Enrollment(Participants) | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Total |
|---|---|---|---|
| ARGENTINA | 0 | 1 | 1 |
| AUSTRALIA | 1 | 1 | 2 |
| BULGARIA | 1 | 2 | 3 |
| CHINA | 7 | 10 | 17 |
| CZECH REPUBLIC | 3 | 1 | 4 |
| DENMARK | 1 | 1 | 2 |
| FRANCE | 2 | 0 | 2 |
| GERMANY | 7 | 4 | 11 |
| HUNGARY | 1 | 1 | 2 |
| ISRAEL | 1 | 0 | 1 |
| ITALY | 3 | 1 | 4 |
| JAPAN | 5 | 9 | 14 |
| LITHUANIA | 0 | 1 | 1 |
| MEXICO | 2 | 2 | 4 |
| POLAND | 4 | 5 | 9 |
| PORTUGAL | 0 | 3 | 3 |
| ROMANIA | 3 | 0 | 3 |
| RUSSIAN FEDERATION | 5 | 0 | 5 |
| SAUDI ARABIA | 1 | 1 | 2 |
| SINGAPORE | 1 | 0 | 1 |
| SLOVAKIA | 1 | 0 | 1 |
| SOUTH KOREA | 3 | 5 | 8 |
| SPAIN | 1 | 1 | 2 |
| TAIWAN | 1 | 1 | 2 |
| THAILAND | 1 | 1 | 2 |
| TURKEY | 2 | 4 | 6 |
| UNITED KINGDOM | 2 | 0 | 2 |
| UNITED STATES | 5 | 8 | 13 |
| AgeContinuous(years) | Double Blind (DB) Period: Macitentan | DB Period: Placebo | Total |
|---|---|---|---|
| Mean | 64.7 ± 11.69 | 60.3 ± 12.84 | 62.5 ± 12.41 |
Showing the first 100 of 168 sites across 33 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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