Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002950-56-DE

Enrollment

Registered

2014-01-23

Start date

2014-03-21

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 18.1 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855

Interventions

Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female = 18 and = 80 years of age. - Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 47 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 31

Exclusion criteria

Exclusion criteria: - Previous pulmonary endarterectomy. - Recurrent thromboembolism despite sufficient oral anticoagulants. - Symptomatic acute pulmonary embolism in the 6-month period prior to randomization. - Known moderate-to-severe restrictive lung disease (i.e., TLC < 60% of predicted value) or obstructive lung disease (i.e., FEV1 < 70% of predicted, with FEV1/FVC < 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema). - Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements in the 3-month period prior to Screening visit or during the Screening period.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) at rest in comparison with placebo in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).;Secondary Objective: • To evaluate the effects of macitentan 10 mg in comparison with placebo on: – Exercise capacity – Dyspnea (assessed by the Borg dyspnea index) – WHO functional class (FC) • To evaluate the safety and tolerability of macitentan 10 mg in this subject population.;Primary end point(s): PVR at rest at Week 16 expressed as percent of baseline PVR at rest;Timepoint(s) of evaluation of this end point: Baseline and Week 16	—

Measure

Time frame

Main Objective: To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) at rest in comparison with placebo in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).;Secondary Objective: • To evaluate the effects of macitentan 10 mg in comparison with placebo on: – Exercise capacity – Dyspnea (assessed by the Borg dyspnea index) – WHO functional class (FC) • To evaluate the safety and tolerability of macitentan 10 mg in this subject population.;Primary end point(s): PVR at rest at Week 16 expressed as percent of baseline PVR at rest;Timepoint(s) of evaluation of this end point: Baseline and Week 16

—

Secondary

Measure	Time frame
Secondary end point(s): - Change from baseline to Week 24 in exercise capacity, as measured by the 6MWD. - Change from baseline to Week 24 in Borg dyspnea index collected at the end of the 6MWT. - Proportion of subjects with worsening in WHO FC from baseline to Week 24.;Timepoint(s) of evaluation of this end point: Baseline and Week 24	—

Countries

Austria, Belgium, Canada, Chile, China, Czech Republic, France, Germany, Hungary, Korea, Republic of, Lithuania, Mexico, Netherlands, Poland, Russian Federation, South Africa, Switzerland, Thailand, Ukraine, United Kingdom, United States, Vietnam

Contacts

Public ContactGlobal Medical Information

Actelion Pharmaceuticals Ltd.

medinfo@actelion.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026