A Phase 2 interventional study of macitentan 10 mg in Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease, sponsored by Actelion. Terminated at 44 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Actelion (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.
Actelion is the lead sponsor of 143 studies on the registry; 1 is open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 25 (89%) have results posted.
First submitted after Actelion became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
oral administration of 10 mg macitentan once daily
Drug: macitentan 10 mg
macitentan 10 mg, film-coated tablet, oral use
Number of Participants With All-cause Deaths up to 30 Days After Study Treatment Discontinuation
Number of participants with all-cause deaths up to 30 days after study treatment discontinuation were reported. All-cause deaths are defined as all anticipated and unanticipated deaths due to any cause.
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks)
Number of Participants With All-cause Hospital Admissions up to 30 Days After Study Treatment Discontinuation
Number of participants with all-cause hospital admissions up to 30 days after study treatment discontinuation were reported.
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) up to 30 Days After Study Treatment Discontinuation
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is a suspected transmission of any infectious agent via a medicinal product, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Any AE and SAE occurring at or after the study treatment start up to 30 days after end of treatment (EOT) within the analysis set was considered to be treatment-emergent.
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks)
Number of Participants With TEAEs Leading to Premature Discontinuation of Study Treatment
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after EOT within the analysis set was considered to be treatment-emergent.
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks)
Change From Baseline in Systolic and Diastolic Arterial Blood Pressure (BP) at Week 24
Change from baseline in systolic and diastolic arterial BP at Week 24 was reported.
Time frame: Baseline and Week 24
Change From Baseline in Systolic and Diastolic Arterial Blood Pressure (BP) at Week 52
Change from baseline in systolic and diastolic arterial BP at Week 52 was reported.
Time frame: Baseline and Week 52
Change From Baseline in Pulse Rate at Week 24
Change from baseline in pulse rate at Week 24 was reported.
Time frame: Baseline and Week 24
Change From Baseline in Pulse Rate at Week 52
Change from baseline in pulse rate at Week 52 was reported.
Time frame: Baseline and Week 52
Change From Baseline in Body Weight at Week 24
Change from baseline in body weight at Week 24 was reported.
Time frame: Baseline and Week 24
Change From Baseline in Body Weight at Week 52
Change from baseline in body weight at Week 52 was reported.
Time frame: Baseline and Week 52
Number of Participants With Treatment-emergent Marked Laboratory Abnormalities (MLAs) up to 30 Days After Study Treatment Discontinuation
Number of participants with treatment-emergent MLAs (Hemoglobin \[grams/Liter{L}\], Hematocrit \[L/L\], Leukocytes \[10\^9cells/L\], Lymphocytes \[10\^9cells/L\], Alanine Aminotransferase \[Units/L {U/L}\], Aspartate Aminotransferase \[U/L\], Bilirubin \[micromoles/L {mcmol/L}\], Alkaline Phosphatase \[U/L\], Creatinine \[mcmol/L\], Urea Nitrogen \[mmol/L\], Urate \[mcmol/L\], Potassium \[mmol/L\], Sodium \[mmol/L\], Magnesium \[mmol/L\], Calcium \[mmol/L\] were reported. Abnormalities that occurred after study treatment start and up to 30 days after study treatment discontinuation, that were not present at baseline, were treatment-emergent. Here, \> signifies greater than; \< signifies less than; ULN signifies upper limit of normal; and L=Low, H=High, LL=low/low, HH=high/high, LLL=lower/worse than LL, HHH=higher/worse than HH.
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks)
Change From Baseline in Hemoglobin at Week 24
Change from baseline in hemoglobin at Week 24 was reported.
Time frame: Baseline and Week 24
Change From Baseline in Hemoglobin at Week 52
Change from baseline in hemoglobin at Week 52 was reported.
Time frame: Baseline and Week 52
Change From Baseline in Leukocytes and Platelets at Week 24
Change from baseline in leukocytes and platelets at Week 24 was reported.
Time frame: Baseline and Week 24
Change From Baseline in Leukocytes and Platelets at Week 52
Change from baseline in leukocytes and platelets at Week 52 was reported.
Time frame: Baseline and Week 52
Change From Baseline in Alanine Aminotransferase and Aspartate Aminotransferase at Week 24
Change from baseline in alanine aminotransferase and aspartate aminotransferase at Week 24 was reported.
Time frame: Baseline and Week 24
Change From Baseline in Alanine Aminotransferase and Aspartate Aminotransferase at Week 52
Change from baseline in alanine aminotransferase and aspartate aminotransferase at Week 52 was reported.
Time frame: Baseline and Week 52
Change From Baseline in Bilirubin at Week 24
Change from baseline in bilirubin at Week 24 was reported.
Time frame: Baseline and Week 24
Change From Baseline in Bilirubin at Week 52
Change from baseline in bilirubin at Week 52 was reported.
Time frame: Baseline and Week 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Change from baseline in eGFR rate at Week 24 was reported.
Time frame: Baseline and Week 24
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Change from baseline in eGFR rate at Week 52 was reported.
Time frame: Baseline and Week 52
| Milestone | Macitentan 10 mg |
|---|---|
| Started | 91 |
| Completed | 76 |
| Not completed | 15 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Death | 11 |
Number of participants with all-cause deaths up to 30 days after study treatment discontinuation were reported. All-cause deaths are defined as all anticipated and unanticipated deaths due to any cause.
| Participants | Macitentan 10 mg |
|---|---|
| Number of Participants With All-cause Deaths up to 30 Days After Study Treatment Discontinuation | 11 |
Number of participants with all-cause hospital admissions up to 30 days after study treatment discontinuation were reported.
| Participants | Macitentan 10 mg |
|---|---|
| Number of Participants With All-cause Hospital Admissions up to 30 Days After Study Treatment Discontinuation | 42 |
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is a suspected transmission of any infectious agent via a medicinal product, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Any AE and SAE occurring at or after the study treatment start up to 30 days after end of treatment (EOT) within the analysis set was considered to be treatment-emergent.
| Participants | Macitentan 10 mg |
|---|---|
| TEAEs | 81 |
| TESAEs | 49 |
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after EOT within the analysis set was considered to be treatment-emergent.
| Participants | Macitentan 10 mg |
|---|---|
| Number of Participants With TEAEs Leading to Premature Discontinuation of Study Treatment | 25 |
Change from baseline in systolic and diastolic arterial BP at Week 24 was reported.
| millimeters of mercury (mmHg) | Macitentan 10 mg |
|---|---|
| Systolic BP | -5.01 ± 13.152 |
| Diastolic BP | -3.34 ± 9.903 |
Change from baseline in systolic and diastolic arterial BP at Week 52 was reported.
| mmHg | Macitentan 10 mg |
|---|---|
| Systolic BP | -2.10 ± 20.855 |
| Diastolic BP | -0.79 ± 11.685 |
Change from baseline in pulse rate at Week 24 was reported.
| beats per minute (bpm) | Macitentan 10 mg |
|---|---|
| Change From Baseline in Pulse Rate at Week 24 | 0.59 ± 9.706 |
Change from baseline in pulse rate at Week 52 was reported.
| bpm | Macitentan 10 mg |
|---|---|
| Change From Baseline in Pulse Rate at Week 52 | 2.62 ± 18.441 |
Change from baseline in body weight at Week 24 was reported.
| kilograms (kg) | Macitentan 10 mg |
|---|---|
| Change From Baseline in Body Weight at Week 24 | 0.25 ± 6.353 |
Change from baseline in body weight at Week 52 was reported.
| kg | Macitentan 10 mg |
|---|---|
| Change From Baseline in Body Weight at Week 52 | -0.16 ± 8.200 |
Number of participants with treatment-emergent MLAs (Hemoglobin \[grams/Liter{L}\], Hematocrit \[L/L\], Leukocytes \[10\^9cells/L\], Lymphocytes \[10\^9cells/L\], Alanine Aminotransferase \[Units/L {U/L}\], Aspartate Aminotransferase \[U/L\], Bilirubin \[micromoles/L {mcmol/L}\], Alkaline Phosphatase \[U/L\], Creatinine \[mcmol/L\], Urea Nitrogen \[mmol/L\], Urate \[mcmol/L\], Potassium \[mmol/L\], Sodium \[mmol/L\], Magnesium \[mmol/L\], Calcium \[mmol/L\] were reported. Abnormalities that occurred after study treatment start and up to 30 days after study treatment discontinuation, that were not present at baseline, were treatment-emergent. Here, \> signifies greater than; \< signifies less than; ULN signifies upper limit of normal; and L=Low, H=High, LL=low/low, HH=high/high, LLL=lower/worse than LL, HHH=higher/worse than HH.
| Participants | Macitentan 10 mg |
|---|---|
| Hemoglobin:LL<100 | 10 |
| Hematocrit: LL(<0.28-females;<0.32-males) | 5 |
| Leukocytes: HH (>20.0) | 1 |
| Lymphocytes: LLL (<0.5) | 1 |
| Lymphocytes: LL (<0.8) | 10 |
| Alanine Aminotransferase: HH (>3 ULN) | 1 |
| Aspartate Aminotransferase: HH (>3 ULN) | 1 |
| Alkaline Phosphatase: HH (>2.5 ULN) | 1 |
| Bilirubin: HH (>2 ULN) | 1 |
| Bilirubin: HHH (>5 ULN) | 1 |
| Creatinine: HH (>1.5 ULN) | 2 |
| Urea Nitrogen: HH (>2.5 ULN) | 3 |
| Urate: HH (>590) | 15 |
| Urate: HHH (>720) | 3 |
| Sodium: LLL (<130) | 3 |
| Potassium: LLL (<3.0) | 1 |
| Potassium: LL (<3.2) | 5 |
| Potassium: HH (>5.5) | 5 |
| Magnesium: HHH (>1.23) | 1 |
| Calcium: LLL (<1.75) | 1 |
| Calcium: LL (<2.0) | 2 |
Change from baseline in hemoglobin at Week 24 was reported.
| grams per liter (g/L) | Macitentan 10 mg |
|---|---|
| Change From Baseline in Hemoglobin at Week 24 | -4.13 ± 11.324 |
Change from baseline in hemoglobin at Week 52 was reported.
| grams per litre (g/L) | Macitentan 10 mg |
|---|---|
| Change From Baseline in Hemoglobin at Week 52 | -1.10 ± 13.241 |
Change from baseline in leukocytes and platelets at Week 24 was reported.
| 10^9 cells/L | Macitentan 10 mg |
|---|---|
| Leukocytes | -0.078 ± 1.6871 |
| Platelets | 1.39 ± 36.102 |
Change from baseline in leukocytes and platelets at Week 52 was reported.
| 10^9 cells/L | Macitentan 10 mg |
|---|---|
| Leukocytes | -0.503 ± 1.5090 |
| Platelets | -9.02 ± 37.285 |
Change from baseline in alanine aminotransferase and aspartate aminotransferase at Week 24 was reported.
| units per liter (U/L) | Macitentan 10 mg |
|---|---|
| Alanine Aminotransferase | -0.49 ± 7.590 |
| Aspartate Aminotransferase | -0.2 ± 7.76 |
Change from baseline in alanine aminotransferase and aspartate aminotransferase at Week 52 was reported.
| U/L | Macitentan 10 mg |
|---|---|
| Alanine Aminotransferase | 0.10 ± 7.529 |
| Aspartate Aminotransferase | 1.2 ± 6.52 |
Change from baseline in bilirubin at Week 24 was reported.
| micromoles per liter (mcmol/L) | Macitentan 10 mg |
|---|---|
| Change From Baseline in Bilirubin at Week 24 | -0.0970 ± 4.20548 |
Change from baseline in bilirubin at Week 52 was reported.
| mcmol/L | Macitentan 10 mg |
|---|---|
| Change From Baseline in Bilirubin at Week 52 | 0.2041 ± 4.65018 |
Change from baseline in eGFR rate at Week 24 was reported.
| milliliters/minute/1.73 meter square | Macitentan 10 mg |
|---|---|
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 | -4.05 ± 11.766 |
Change from baseline in eGFR rate at Week 52 was reported.
| milliliters/minute/1.73 meter square | Macitentan 10 mg |
|---|---|
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | -1.80 ± 13.510 |
Collected over Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Macitentan 10 mg | 11/91 (12.1%) | 49/91 (53.8%) | 45/91 (49.5%) |
| Event | Macitentan 10 mg |
|---|---|
| Cardiac Failure CongestiveCardiac disorders | 6/91 |
| Right Ventricular FailureCardiac disorders | 5/91 |
| Acute Kidney InjuryRenal and urinary disorders | 5/91 |
| Left Ventricular FailureCardiac disorders | 3/91 |
| Covid-19 PneumoniaInfections and infestations | 3/91 |
| PneumoniaInfections and infestations | 3/91 |
| AnaemiaBlood and lymphatic system disorders | 2/91 |
| Atrial FibrillationCardiac disorders | 2/91 |
| Gastrointestinal HaemorrhageGastrointestinal disorders | 2/91 |
| Cholecystitis AcuteHepatobiliary disorders | 2/91 |
| Event | Macitentan 10 mg |
|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 11/91 |
| Urinary Tract InfectionInfections and infestations | 9/91 |
| Oedema PeripheralGeneral disorders | 7/91 |
| Back PainMusculoskeletal and connective tissue disorders | 7/91 |
| DizzinessNervous system disorders | 7/91 |
| AnaemiaBlood and lymphatic system disorders | 6/91 |
| Right Ventricular FailureCardiac disorders | 6/91 |
| ConstipationGastrointestinal disorders | 6/91 |
| Pain in ExtremityMusculoskeletal and connective tissue disorders | 6/91 |
| NauseaGastrointestinal disorders | 5/91 |
| Age, Continuous(years) | Macitentan 10 mg |
|---|---|
| Mean | 72.7 ± 9.21 |
| Age, Customized(Participants) | Macitentan 10 mg |
|---|---|
| From 18 to 64 years | 14 |
| From 65 to 84 years | 69 |
| 85 years and over | 8 |
| Sex: Female, Male(Participants) | Macitentan 10 mg |
|---|---|
| Female | 59 |
| Male | 32 |
| Ethnicity (NIH/OMB)(Participants) | Macitentan 10 mg |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 86 |
| Unknown or Not Reported | 1 |
| Race/Ethnicity, Customized(Participants) | Macitentan 10 mg |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Black or African American | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| White | 87 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Other | 2 |
| Region of Enrollment(Participants) | Macitentan 10 mg |
|---|---|
| ARGENTINA | 1 |
| AUSTRIA | 2 |
| BRAZIL | 2 |
| BULGARIA | 8 |
| DENMARK | 2 |
| FRANCE | 5 |
| GERMANY | 4 |
| ISRAEL | 23 |
| POLAND | 7 |
| ROMANIA | 4 |
| RUSSIAN FEDERATION | 14 |
| SWEDEN | 2 |
| UNITED KINGDOM | 3 |
| UNITED STATES | 14 |
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 Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.janssen.com
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Studies of the drug tested here: Macitentan