Study ID: UNISUS
Outcome study assessing a 75 mg dose of macitentan in patients with pulmonary arterial hypertension
This randomized, phase 3 study seeks to determine if 75 mg of the FDA-approved medication Opsumit® (macitentan) is better at treating symptomatic pulmonary arterial hypertension than 10 mg of the drug. Opsumit is in a class of drugs called endothelin receptor antagonists (ERA), which dilate constricted vessels.
Participants who have never taken an ERA medication first receive 10 mg of macitentan orally daily for 4 weeks before being randomized into a study group. Those who have taken ERA medications previously are directly randomized into a study arm.
Patients in the two study groups receive the following daily:
- Arm 1 receives macitentan 10 mg orally and placebo for 4 weeks, and then 75 mg of macitentan thereafter until the end of the double-blind treatment period. During a treatment extension period, participants receive 37.5 mg of mactientan and placebo for 4 weeks.
- Arm 2 receives maceitentan 37.5 mg and a placebo for 4 weeks, then 75 mg and a placebo until the end of the double-blind treatment period. During a treatment extension period, Arm 2 participants receive 75 mg of mactientan and placebo for 4 weeks.
Both groups then receive mactitentan (75 mg) alone daily for 2 years.
Note: There are body weight restrictions to this trial. The trial coordinator can give further details.
This is a phase III, prospective, multicenter, double-blind, randomized study to compare efficacy, safety and tolerability of macitentan 75 mg vs. 10 mg in patients with pulmonary arterial hypertension (PAH). It is followed by an open-label treatment period with macitentan 75 mg.Eligible participants must have been diagnosed with symptomatic PAH confirmed by hemodynamic evaluation.
Patients are excluded from this trial if there is a known presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction at screening, based on records that confirm documented medical history:
- body mass index > 30 kilograms per meter square (kg/m^2)
- diabetes mellitus of any type
- essential hypertension (even if well controlled)
- coronary artery disease (i.e., any of the following): history of stable angina, or known more than 50% stenosis in a coronary artery, or history of myocardial infarction, or history of or planned coronary artery bypass grafting and/or coronary artery stenting.
- Must have been diagnosed with symptomatic pulmonary arterial hypertension
- Must be able to perform a 6-minute walking test at time of screening