UNISUS
Research type
Research Study
Full title
A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Activecontrolled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg.
IRAS ID
279159
Contact name
Gerry Coghlan
Contact email
Sponsor organisation
ACTELION Pharmacteuticals Ltd.
Eudract number
2019-002533-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 6 months, 2 days
Research summary
Pulmonary arterial hypertension (PAH) is a syndrome characterized by a persistent increase in pulmonary vascular resistance (PVR) progressing to right heart failure and death. It remains a severe and incurable disease despite the availability of multiple drugs.
Although significant progress has been made in the treatment of PAH, which has resulted in a substantial improvement of long-term survival for PAH patients, there is still a clear unmet medical need to further delay disease progression (and death) and reduce hospitalization for PAH.
The efficacy of macitentan 10 mg in the treatment of patients with PAH is well established. However it is expected that macitentan 75 mg qd will offer additional efficacy benefits.
The purpose of this study is to compare efficacy, safety, and tolerability of macitentan 75 mg versus macitentan 10 mg, in patients with PAH, administered as monotherapy or in combination with other PAH therapies. The primary endpoint will be time to first CEC-adjudicated morbidity or mortality (M/M) event on-treatment.
Patients that are eligible to take part will be randomised in a 1:1 ratio to either a 10mg macitentan treatment arm or a 75mg macitentan treatment arm. All participants will also receive matching placebo to maintain the study blinding.
The study will be conducted in five phases consisting of a screening period of up to 30 days, a run-in period (if needed) of 4 weeks, a blinded treatment period of up to 4 years, an open-label treatment period of about 2 years and a safety follow up period of 30 days.the duration of the study is expected to be up to 6 years and 3 months.
the study will be conducted at NHS specialist PH centres in the United Kingdom.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0256
Date of REC Opinion
30 Jun 2020
REC opinion
Favourable Opinion