Macitentan 10 mg: Clinical Trials

11 trials of Macitentan 10 mg, newest first

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6 completed, 4 terminated, 1 active not recruiting. 7 Phase 3, 3 Phase 1, 1 Phase 2.

By phase and status

PhaseTrialsStatus
Phase 37Completed 3, Terminated 3, Active not recruiting 1
Phase 13Completed 3
Phase 21Terminated 1

Follow Macitentan 10 mg: new trials by email Literature Review of Macitentan 10 mg trials Research Report on Macitentan 10 mg

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
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 1CompletedActelion402022-02-042025-03-30
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 1CompletedJanssen Research & Development, LLC182021-04-302025-03-30
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 3Active not recruitingActelion9352020-06-302026-10-06
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 3CompletedActelion1872019-07-292025-12-19
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 3TerminatedActelion1122019-04-112023-03-07
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 3TerminatedActelion92019-01-082021-06-18
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 2TerminatedActelion912018-12-072025-02-04
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
Macitentan 10 mg, Placebo - Congenital Heart Disease
Phase 3CompletedActelion1422017-08-142025-03-30
Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
Macitentan 10 mg, Placebo - Pulmonary Arterial Hypertension
Phase 3CompletedActelion2262013-05-212018-02-23
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Macitentan 3 mg, Macitentan 10 mg, Placebo - Digital Ulcers
Phase 3TerminatedActelion2652011-12-012025-02-04
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 1CompletedActelion642011-08-012025-02-03

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)