High-Dose Macitentan for PAH
(UNISUS Trial)

Recruiting in Palo Alto (17 mi)

+340 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Actelion

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if a higher dose of macitentan can better help patients with pulmonary arterial hypertension by improving blood flow in their lungs. Macitentan has shown promise in helping patients by slowing down the disease and improving their health.

Research Team

Actelion Clinical Trials

Principal Investigator

Actelion

Eligibility Criteria

Adults with symptomatic Pulmonary Arterial Hypertension (PAH) in various severity classes, confirmed by specific heart and lung pressure measurements. Eligible participants include those with PAH due to different causes such as genetic factors, drug use, or associated diseases like HIV. They must be able to perform a walking test and not have severe liver issues, certain blood disorders, or significant risk factors for heart failure.

Inclusion Criteria

I am 18 years old or older.

I can complete a 6-minute walking test.

You have been diagnosed with pulmonary arterial hypertension (PAH) based on specific measurements of your heart and lung pressures.

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Exclusion Criteria

You have three or more factors that increase your risk of heart failure with preserved ejection fraction.

Your hemoglobin level is less than 100 grams per liter at the time of screening.

I have a known liver condition that is moderate to severe.

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Treatment Details

Interventions

Macitentan (Endothelin Receptor Antagonist)

Trial OverviewThe trial is testing the effectiveness of a higher dose of Macitentan (75 mg) compared to the standard dose (10 mg) in delaying health deterioration or death in PAH patients. Participants will randomly receive either the high dose, standard dose, an intermediate dose (37.5 mg), or a placebo.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Macitentan 75 mg + PlaceboExperimental Treatment4 Interventions

Run-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan \<10 mg, or a daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participants will receive macitentan 37.5 mg orally for 4 weeks and macitentan 75 mg thereafter up to End of DBT. To maintain the blind, participants will receive macitentan 10 mg-matching placebo up to End of DBT.Treatment Extension Period: After EDBT, participants will continue to receive macitentan 75 mg orally for 2 years. To maintain the blind, participants will receive macitentan 37.5 mg-matching placebo during the 4-week up-titration period.

Group II: Macitentan 10 milligrams (mg) + PlaceboActive Control4 Interventions

Run-in period:Participants who are either endothelin receptor antagonist (ERA)-naïve or who are receiving daily dose of macitentan or ambrisentan less (\<) 10 milligrams (mg), or daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration.