Chronic Thromboembolic Pulmonary HypertensionPhase 2MERIT-2NCT02060721

Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

A Phase 2 study testing Macitentan in people with Chronic Thromboembolic Pulmonary Hypertension, run by Actelion at 33 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Thromboembolic Pulmonary Hypertension
What is being tested?: Macitentan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 33 sitesin 15 countries
Study dates: 3 Feb 2015to 21 Mar 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent
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).
Females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.

Who cannot join

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.

Trial locations and contacts

33 sites in 15 countries.

Country

City, postcode or hospital

33 sites in 15 countries

China5 sites

Study site
Beijing
Study site
Guangzhou
Study site
Shanghai
Study site
Shenyang
Study site
Wuhan

Other trials in China

Russia5 sites

Study site
Kemerovo
Study site
Moscow
Study site
Novosibirsk
Study site
Saint Petersburg
Study site
Tomsk

Other trials in Russia

France3 sites

Study site
Le Kremlin-Bicêtre
Study site
Paris
Study site
Toulouse

Other trials in France

Germany3 sites

Study site
Giessen
Study site
Heidelberg
Study site
Würzburg

Other trials in Germany

United Kingdom3 sites

Study site
Cambridge
Study site
London
Study site
Sheffield

Other trials in United Kingdom

Hungary2 sites

Study site
Budapest
Study site
Debrecen

Other trials in Hungary

Poland2 sites

Study site
Lublin
Study site
Wroclaw

Other trials in Poland

Thailand2 sites

Study site
Bangkok
Study site
Chiang Mai

Other trials in Thailand

Ukraine2 sites

Study site
Kyiv
Study site
Lviv

Other trials in Ukraine

Belgium1 site

Study site
Leuven

Other trials in Belgium

Czechia1 site

Study site
Prague

Other trials in Czechia

Lithuania1 site

Study site
Kaunas

Other trials in Lithuania

Mexico1 site

Study site
Mexico City

Other trials in Mexico

Switzerland1 site

Study site
Zurich

Other trials in Switzerland

Turkey (Türkiye)1 site

Study site
Capa_Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

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)

Conditions: Chronic Thromboembolic Pulmonary Hypertension
Being tested: Macitentan
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MacitentanDrug
Also called ACT-064992
Macitentan 10mg, oral tablet, once daily

Study groups in NCT02060721
Study group	Role	What they receive
Macitentan	Experimental	Macitentan 10mg, oral tablet, once daily Receives: Drug: Macitentan

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Measured: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of Participants With AEs Leading to Study Drug Discontinuation
Number of participants with AEs leading to study drug discontinuation was reported.
Measured: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Measured: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of Participants With Hemoglobin Abnormalities
Number of participants with hemoglobin abnormalities were reported. It included hemoglobin less than (<) 80 grams per liter (g/L), hemoglobin <100 g/L, hemoglobin greater than or equal to (>=) 80 g/L and <100 g/L, hemoglobin <100g/L and a decrease of >20 g/L from baseline, decrease of >20 g/L in hemoglobin from baseline, decrease of >20 g/L and <=50 g/L in hemoglobin from baseline, and decrease of >50 g/L in hemoglobin from baseline.
Measured: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of Participants With Liver Tests Abnormalities
Number of participants with liver tests abnormalities were reported. It included alanine aminotransferase (ALT) or aspartate aminotransferase (AST): >=3 x Upper limit of the normal range (ULN), >=3 and <5 x ULN, >=5 ULN, and >=5 and <8 x ULN, >= 8 x ULN, and total bilirubin >=2 x ULN.
Measured: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Change From Baseline in Blood Pressure at Month 6
Change from baseline in blood pressure at Month 6 (both systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was reported.
Measured: Baseline and Month 6
Change From Baseline in Pulse Rate at Month 6
Change from baseline in pulse rate at Month 6 was reported.
Measured: Baseline and Month 6
Change From Baseline in Body Weight at Month 6
Change from baseline in body weight at Month 6 was reported.
Measured: Baseline and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 201521 Mar 2022

First posted12 Feb 2014 (estimated)
Study start3 Feb 2015
Primary completion21 Mar 2022
Study completion21 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02060721
Sponsor's protocol ID: AC-055E202
Other IDs: 2013-003457-25
Acronym: MERIT-2
Status last verified: Mar 2025
First submitted: 2 Jan 2014
Last updated: 30 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kim NH, D'Armini AM, Howard LS, Jenkins DP, Jing ZC, Mayer E, Chamitava L, Lack G, Rofael H, Solonets M, Ghofrani HA. Long-Term Safety and Efficacy of Macitentan in Inoperable Chronic Thromboembolic Pulmonary Hypertension: Results from MERIT and its Open-Label Extension. Pulm Ther. 2025 Mar;11(1):101-116. doi: 10.1007/s41030-024-00276-w. Epub 2024 Nov 9.
PubMed 39520648

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
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Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

All Chronic Thromboembolic Pulmonary Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
ClinicalTrials.gov ID: NCT02060721
Acronym / sponsor ID: MERIT-2 / AC-055E202
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: ActelionIndustry (pharma, biotech, devices)
Study start: 3 Feb 2015 (actual)
Primary completion: 21 Mar 2022 (actual)
Study completion: 21 Mar 2022 (actual)
First posted: 12 Feb 2014 (estimated)
Results: Posted 11 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Macitentan	Experimental	Drug: MacitentanMacitentan 10mg, oral tablet, once daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Written informed consent
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).
Females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MacitentanAlso: ACT-064992Macitentan 10mg, oral tablet, once daily	Drug	Macitentan

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Number of Participants With AEs Leading to Study Drug Discontinuation
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of participants with AEs leading to study drug discontinuation was reported.
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Number of Participants With Hemoglobin Abnormalities
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of participants with hemoglobin abnormalities were reported. It included hemoglobin less than (<) 80 grams per liter (g/L), hemoglobin <100 g/L, hemoglobin greater than or equal to (>=) 80 g/L and <100 g/L, hemoglobin <100g/L and a decrease of >20 g/L from baseline, decrease of >20 g/L in hemoglobin from baseline, decrease of >20 g/L and <=50 g/L in hemoglobin from baseline, and decrease of >50 g/L in hemoglobin from baseline.
Number of Participants With Liver Tests Abnormalities
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of participants with liver tests abnormalities were reported. It included alanine aminotransferase (ALT) or aspartate aminotransferase (AST): >=3 x Upper limit of the normal range (ULN), >=3 and <5 x ULN, >=5 ULN, and >=5 and <8 x ULN, >= 8 x ULN, and total bilirubin >=2 x ULN.
Change From Baseline in Blood Pressure at Month 6
Time frame: Baseline and Month 6
Change from baseline in blood pressure at Month 6 (both systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was reported.
Change From Baseline in Pulse Rate at Month 6
Time frame: Baseline and Month 6
Change from baseline in pulse rate at Month 6 was reported.
Change From Baseline in Body Weight at Month 6
Time frame: Baseline and Month 6
Change from baseline in body weight at Month 6 was reported.

Results and safety

Results posted to the registry on 11 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Macitentan 10 Milligrams (mg)	76	38

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months). Count of participants. Unit: Participants

Measure	Macitentan 10 Milligrams (mg) n = 76
Value	72

Population analysed: Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.

Primary outcome: Number of Participants With AEs Leading to Study Drug Discontinuation

Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months). Count of participants. Unit: Participants

Measure	Macitentan 10 Milligrams (mg) n = 76
Value	9

Population analysed: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.

Primary outcome: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months). Count of participants. Unit: Participants

Measure	Macitentan 10 Milligrams (mg) n = 76
Value	44

Population analysed: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.

Primary outcome: Number of Participants With Hemoglobin Abnormalities

Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months). Count of participants. Unit: Participants

Measure	Macitentan 10 Milligrams (mg) n = 76
Hemoglobin < 80 g/L	0
Hemoglobin <100 g/L	7
Hemoglobin >= 80 g/L and <100 g/L	7
Hemoglobin <100g/L and a decrease of >20 g/L from baseline	6
Decrease of >20 g/L in hemoglobin from baseline	32
Decrease of >20 g/L and <=50 g/L in hemoglobin from baseline	31
Decrease of >50 g/L in hemoglobin from baseline	5

Population analysed: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.

Adverse events

Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Macitentan 10 Milligrams (mg)	44 of 76 (57.9%)	67 of 76 (88.2%)	14 of 76

Limitations and caveats (from the sponsor): Study limitations included the open-label (OL), uncontrolled design, and small sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39520648Kim NH, D'Armini AM, Howard LS, Jenkins DP, Jing ZC, Mayer E, Chamitava L, Lack G, Rofael H, Solonets M, Ghofrani HA. Long-Term Safety and Efficacy of Macitentan in Inoperable Chronic Thromboembolic Pulmonary Hypertension: Results from MERIT and its Open-Label Extension. Pulm Ther. 2025 Mar;11(1):101-116. doi: 10.1007/s41030-024-00276-w. Epub 2024 Nov 9.

Related trials for Chronic Thromboembolic Pulmonary Hypertension

Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
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Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erin McGuire study director

Actelion

33 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Macitentan in people with Chronic Thromboembolic Pulmonary Hypertension, run by Actelion at 33 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in China, Russia, France, Germany, United Kingdom and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02060721, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.