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

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003457-25-CZ

Enrollment

Registered

2014-04-01

Start date

2014-06-13

Completion date

Unknown

Last updated

2022-04-19

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: 20.0 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject with CTEPH having completed the double-blind (DB) AC-055E201 / MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24). 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: - Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities. - Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects with inoperable CTEPH - To evaluate the long term effects of macitentan 10 mg on exercise capacity and functional class (FC).;Secondary Objective: Not Applicable;Primary end point(s): Evaluation of the long-term safety and tolerability: - Treatment-emergent AEs up to 30 days after study drug discontinuation. - AEs leading to premature discontinuation of study drug. - Treatment-emergent SAEs up to 30 days after study drug discontinuation. - Treatment-emergent marked laboratory abnormalities up to 30 days after study drug discontinuation. - Change in vital signs (blood pressure , heart rate) and body weight from baseline to all assessed time points during the study;Timepoint(s) of evaluation of this end point: From baseline up to 30 days after study drug discontinuation.	—

Measure

Time frame

Main Objective: - To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects with inoperable CTEPH - To evaluate the long term effects of macitentan 10 mg on exercise capacity and functional class (FC).;Secondary Objective: Not Applicable;Primary end point(s): Evaluation of the long-term safety and tolerability: - Treatment-emergent AEs up to 30 days after study drug discontinuation. - AEs leading to premature discontinuation of study drug. - Treatment-emergent SAEs up to 30 days after study drug discontinuation. - Treatment-emergent marked laboratory abnormalities up to 30 days after study drug discontinuation. - Change in vital signs (blood pressure , heart rate) and body weight from baseline to all assessed time points during the study;Timepoint(s) of evaluation of this end point: From baseline up to 30 days after study drug discontinuation.

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Secondary

Measure	Time frame
Secondary end point(s): Change from baseline to each scheduled time point in exercise capacity, as measured by the 6MWD. ;Timepoint(s) of evaluation of this end point: Baseline up to 30 months.	—

Countries

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

Contacts

Public ContactClinical Trials Disclosure Desk

Actelion Pharmaceuticals Ltd.

clinical-trials-disclosure@actelion.com

Outcome results

None listed

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