38 completed, 13 terminated, 5 withdrawn, 3 recruiting. 25 Phase 3, 17 Phase 1, 11 Phase 2, 6 Phase 4, 2 Early Phase 1.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Mechanisms of Macitentan for Non-Coronary Obstructive Angina Macitentan 10 mg tablet, once daily. - Non-Coronary Obstructive Angina | Early Phase 1 | Recruiting | China-Japan Friendship Hospital | 40 | 2025-09-01 | 2026-02-06 |
| Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH Macitentan Tablets, Riociguat, balloon pulmonary angioplasty - CTEPH | Phase 3 | Terminated | Dr Sudarshan Rajagopal | 7 | 2025-01-27 | 2026-09-03 |
| Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina (MACMIC) Macitentan 10 mg tablet, once daily. - Coronary Microvascular Angina, Macitentan | Early Phase 1 | Recruiting | China-Japan Friendship Hospital | 30 | 2024-11-01 | 2025-02-06 |
| Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg Macitentan and Tadalafil film-coated tablets, PrOpsynvi® macitentan and tadalafil film-coated tablets - PAH | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | 30 | 2024-05-14 | 2024-08-14 |
| Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg Macitentan and Tadalafil, PrOpsynvi® Film-Coated Tablets - PAH | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | 30 | 2024-05-10 | 2024-09-19 |
| Macitentan to Prevent PRVO Macitentan 10mg - Pulmonary Embolism | Phase 3 | Withdrawn | University of Maryland, Baltimore | 2024-05-01 | 2024-03-08 | |
| A Study of Macitentan in Children Below 2 Years of Age Macitentan - Arterial Hypertension, Pulmonary | Phase 1 | Withdrawn | Actelion | 2024-03-14 | 2025-03-30 | |
| A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension Macitentan - Pulmonary Arterial Hypertension | Phase 3 | Completed | Janssen Pharmaceutical K.K. | 7 | 2022-11-14 | 2026-05-07 |
| Early Postoperative Triple Targeted Therapy in Patients With CHD-PAH in the "Grey Zone" Control group (ambrisentan plus tadalafil or macitentan plus tadalafil), Treatment group (ambrisentan plus tadalafil plus treprostinil or macitentan plus tadalafil plus treprostinil) - Congenital Heart Disease, Pulmonary Hypertension | Not applicable | Completed | China National Center for Cardiovascular Diseases | 30 | 2022-08-25 | 2026-09-28 |
| A Study of Two Macitentan Formulations in Healthy Adult Participants Macitentan - Healthy | Phase 1 | Completed | Actelion | 28 | 2022-06-22 | 2025-03-30 |
| A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Participants Macitentan - Healthy | Phase 1 | Completed | Actelion | 23 | 2022-05-25 | 2025-03-30 |
| Endothelin-1 and Cardiac Allograft Vasculopathy (CAV) Macitentan - Cardiac Allograft Vasculopathy | Phase 4 | Completed | University of California, Los Angeles | 19 | 2022-05-19 | 2024-03-12 |
| A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option Macitentan, Selexipag, Macitentan/Tadalafil FDC - Hypertension, Pulmonary | Phase 3 | Recruiting | Actelion | 280 | 2022-05-04 | 2026-09-25 |
| A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants Macitentan 10 mg, Tadalafil 20 mg, Macitentan 10 mg/Tadalafil 20mg FDC - Healthy | Phase 1 | Completed | Actelion | 40 | 2022-02-04 | 2025-03-30 |
| A Study of Two Macitentan Pediatric Formulations in Healthy Adult Participants Macitentan - Healthy | Phase 1 | Completed | Actelion | 16 | 2021-07-08 | 2025-03-30 |
| Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension Macitentan 10mg, Placebo - Thromboembolic Pulmonary Hypertension, Chronic Disease | Phase 2 / Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 96 | 2021-06-14 | 2025-07-20 |
| A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil FDC of macitentan/tadalafil (10 mg/20 mg), Macitentan 10 mg, Tadalafil 20 mg - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 18 | 2021-04-30 | 2025-03-30 |
| A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension Macitentan, Placebo - Chronic Thromboembolic Pulmonary Hypertension | Phase 3 | Terminated | Actelion | 127 | 2020-07-07 | 2025-06-27 |
| Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension Macitentan 10 mg, Macitentan 37.5 mg, Macitentan 75 mg - Pulmonary Arterial Hypertension | Phase 3 | Active not recruiting | Actelion | 935 | 2020-06-30 | 2026-10-06 |
| A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants FDC of Macitentan and Tadalafil, Macitentan, Tadalafil - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 62 | 2020-01-17 | 2025-03-30 |
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Pulmonary Arterial Hypertension (21) · Hypertension, Pulmonary (7) · Eisenmenger Complex (2) · Glioblastoma (2) · Heart Defects, Congenital (2) · Idiopathic Pulmonary Fibrosis (2) · Scleroderma, Systemic (2) · digital ulcers (2) · Anemia, Sickle Cell (1) · Bronchiolitis Obliterans (1) · Chronic Disease (1) · Lung Diseases, Interstitial (1) · Pulmonary Embolism (1) · Pulmonary Fibrosis (1) · Scleroderma, Diffuse (1)
Actelion (45) · China-Japan Friendship Hospital (2) · Humanis Saglık Anonim Sirketi (2) · Janssen Research & Development, LLC (2) · University of California, Los Angeles (2) · Amsterdam UMC, location VUmc (1) · Assistance Publique - Hôpitaux de Paris (1) · Boston University (1) · China National Center for Cardiovascular Diseases (1) · Dr Sudarshan Rajagopal (1) · Franz Rischard, DO (1) · Janssen Pharmaceutical K.K. (1) · University of Maryland, Baltimore (1)
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Gary Palmer, MD, MBA (2) · Loic Perchenet, PhD (2) · Shirin Bruderer, PhD (2) · Alain Romero, MD (1) · Alain Romero, PharmD, PhD (1) · Anton Vonk Noordegraaf, MD, PhD (1) · David J Ross, MD (1) · Elizabeth Klings, MD (1) · Erin McGuire (1) · Franz P. Rischard, DO (1)
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