6 completed, 4 terminated, 1 active not recruiting. 7 Phase 3, 3 Phase 1, 1 Phase 2.
By phase and status
Follow Macitentan 10 mg: new trials by email Literature Review of Macitentan 10 mg trials Research Report on Macitentan 10 mg
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 |
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 | 40 | 2022-02-04 | 2025-03-30 |
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 | 18 | 2021-04-30 | 2025-03-30 |
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 | 935 | 2020-06-30 | 2026-10-06 |
Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) FDC macitentan/tadalafil, Macitentan 10 mg, Tadalafil 40 mg - Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) | Phase 3 | Completed | 187 | 2019-07-29 | 2025-12-19 |
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients. macitentan 10 mg - Congenital Heart Disease With Fontan Circulation | Phase 3 | Terminated | 112 | 2019-04-11 | 2023-03-07 |
A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH). macitentan 10 mg - Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Phase 3 | Terminated | 9 | 2019-01-08 | 2021-06-18 |
A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease macitentan 10 mg - Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease | Phase 2 | Terminated | 91 | 2018-12-07 | 2025-02-04 |
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects Macitentan 10 mg, Placebo - Congenital Heart Disease | Phase 3 | Completed | 142 | 2017-08-14 | 2025-03-30 |
Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome Macitentan 10 mg, Placebo - Pulmonary Arterial Hypertension | Phase 3 | Completed | 226 | 2013-05-21 | 2018-02-23 |
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients Macitentan 3 mg, Macitentan 10 mg, Placebo - Digital Ulcers | Phase 3 | Terminated | 265 | 2011-12-01 | 2025-02-04 |
Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects Moxifloxacin 400 mg, Macitentan 10 mg, Macitentan 30 mg - Healthy | Phase 1 | Completed | 64 | 2011-08-01 | 2025-02-03 |
Conditions studied
Pulmonary Arterial Hypertension (3) · Eisenmenger Complex (1) · Heart Defects, Congenital (1) · Scleroderma, Systemic (1) · Univentricular Heart (1) · digital ulcers (1)
Sponsors
Actelion (10) · Janssen Research & Development, LLC (1)
Countries
United States (7) · Poland (6) · China (5) · France (5) · Germany (5) · United Kingdom (5) · Australia (4) · Bulgaria (4) · Canada (4) · Czechia (4) · Denmark (4) · Russia (4) · Taiwan (4) · Austria (3) · Brazil (3)
Top investigators
Hany Rofael, MD (1) · Nicolas Lindegger, PhD (1) · Thierry Francis Briand, MD (1) · William Byra, MD (1) · Yoshinari Yokoyama, PhD (1)
Results publications
PMID 27163986, PMID 30586694, PMID 38267108, PMID 40066571, PMID 41250682, PMID 41820779, PMID 42023995
NIH funding
2018 (2), 2014 (1), 2016 (1), 2019 (1)