Chronic Thromboembolic Pulmonary HypertensionPhase 2MERIT-1NCT02021292

Clinical Study to Assess the Efficacy, Safety and Tolerability 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 36 sites in 16 countries.

Completed

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

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 84 years
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?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 36 sitesin 16 countries
Study dates: 20 Aug 2014to 28 Sep 2016
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 to 84 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent
Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease).
Female 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

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.

Trial locations and contacts

36 sites in 16 countries.

Country

City, postcode or hospital

36 sites in 16 countries

China6 sites

Beijing Chao-Yang Hospital-Department of Respiration
Beijing, 100020
Cardiovascular institute & Fuwai Hospital- Thrombus Center
Beijing, 100037
The first affiliated hospital of guangzhou medical university-respiratory department
Guangzhou, 510120
ngShanghai Pulmonary Hospital, Department of Pulmonary Circulation
Shanghai, 200433
The General Hospital of Shenyang Military Region,Congenital Heart Disease Department
Shenyang, 110016
Wuhan Asia Heart Hospital
Wuhan, 430022

Other trials in China

Russia5 sites

Federal State Budgetary Institution "Scientific Research Institute of Systemic Problems of Cardiovascular Diseases", Siberian branch of RAMS
Kemerovo, 650002
Federal State Budgetary Institution "Russian Cardiology Scientific and Production Complex" of the Ministry of Health Care of the Russian Federation
Moscow, 121552
E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rosmedtechnology
Novosibirsk, 630055
Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies"
Saint Petersburg, 197341
Federal State Budgetary Institution "Research Institute for Cardiology" of Siberian Branch under the Russian Academy of Medical Sciences / Cardiovascular Surgery Department
Tomsk, 634012

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France3 sites

CHU de Bicêtre
Le Kremlin-Bicêtre, 94275
Hôpital Européen Georges Pompidou Service de Pneumologie, soins intensifs et endoscopies bronchiques
Paris, 75908
CHU de Toulouse Hopital Larrey
Toulouse, 31059

Other trials in France

Germany3 sites

Justus-Liebig-Universität Gießen
Giessen, 35392
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, 69126
Missionsärztliche Klinik gGmbH Akademisches Lehrkrankenhaus der Julius-Maximilians-Universität
Würzburg, 97074

Other trials in Germany

Thailand3 sites

King Chulalongkorn Memorial Hospital, Division of Respiratory and Respiratory Critical Care Medicine
Bangkok, 10330
Siriraj Hospital, Division of Respiratory Disease and Tuberculosis
Bangkok, 10700
MAHARAJ NAKORN CHIANG MAI HOSPITAL, Department of Internal Medicine
Chiang Mai, 50200

Other trials in Thailand

United Kingdom3 sites

Papworth Hospital NHS Trust, Pulmonary Vascular Diseases Unit
Cambridge, CB23 3RE
Hammersmith Hospital
London, W12 0HS
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Pulmonary Vascular Medicine
Sheffield, S10 2RX

Other trials in United Kingdom

Hungary2 sites

Semmelweis Egyetem
Budapest, 1125
Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Kardiológiai Klinika
Debrecen, 4032

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Poland2 sites

Wojewódzki Szpital Specjalistyczny w Lublinie im. Stefana Kardynała Wyszyńskiego SPZOZ Oddział Kardiologii - Pododdział Intensywnego Nadzoru Kardiologicznego
Lublin, 20-718
Wojewódzki Szpital Specjalistyczny we Wrocawiu
Wrocaw, 51-124

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Ukraine2 sites

State Institute of Phthisiology and Pulmonology n.a. F.G. Yanovskiy of AMS Ukraine
Kyiv, 03680
Lviv Regional Clinical Hospital, Cardiosurgery Department
Lviv, 79014

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Belgium1 site

University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie
Leuven, 3000

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Czechia1 site

Centre for PPH, Charles University , II Interni klinika1.LF a VFN
Prague, 128 08

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Lithuania1 site

Lietuvos Sveikatos Mokslų Universiteto Ligoninės Kauno Klinikos Pulmonologijos-Imunologijos Klinika
Kaunas, 50161

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Mexico1 site

Instituto Nacional de Cardiologia (INC) Ignacio Chavez
Mexico City, 14080

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South Korea1 site

Severance Hospital, YonSei University Health System
Seoul, 3722

Other trials in South Korea

Switzerland1 site

University Hospital Zürich
Zurich, 8091

Other trials in Switzerland

Turkey (Türkiye)1 site

Istanbul University İstanbul Faculty Medicine Pulmonology Department
Capa_Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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

Conditions: Chronic Thromboembolic Pulmonary Hypertension
Being tested: Macitentan, Placebo
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 10 mg, oral tablet, to be taken once daily.
PlaceboDrug
Matching placebo oral tablet, to be taken once daily.

Study groups in NCT02021292
Study group	Role	What they receive
Macitentan	Experimental	Macitentan 10 mg, oral tablet, to be taken once daily. Receives: Drug: Macitentan
Placebo	Placebo comparator	Matching placebo oral tablet, to be taken once daily. Receives: Drug: Placebo

What is being measured

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

Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.
The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.
Measured: From baseline to Week 16

Secondary outcomes (3)

Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).
The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Measured: From baseline to Week 24
Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).
This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 24 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement.
Measured: From baseline to Week 24
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
WHO functional classes are defined as follows: 1) class I: no symptoms with exercise or at rest. No limitation of activity. 2) class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). 3) class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. 4) class IV: symptoms at rest (such as dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms (e.g. may faint especially while bending over with their heads lowered). Patients in class IV manifest signs of right heart failure. Shifting to a higher class (e.g. from class III to class IV) represents a 'worsening' while shifting to a lower class (e.g. from class III to class II) means an 'improvement'.
Measured: From baseline to Week 24

Timeline

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

20 Aug 201428 Sep 2016

First posted27 Dec 2013 (estimated)
Study start20 Aug 2014
Primary completion28 Sep 2016
Study completion28 Sep 2016

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 (3)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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02021292
Sponsor's protocol ID: AC-055E201
Acronym: MERIT-1
Status last verified: Mar 2025
First submitted: 20 Dec 2013
Last updated: 30 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ghofrani HA, Simonneau G, D'Armini AM, Fedullo P, Howard LS, Jais X, Jenkins DP, Jing ZC, Madani MM, Martin N, Mayer E, Papadakis K, Richard D, Kim NH; MERIT study investigators. Macitentan for the treatment of inoperable chronic thromboembolic pulmonary hypertension (MERIT-1): results from the multicentre, phase 2, randomised, double-blind, placebo-controlled study. Lancet Respir Med. 2017 Oct;5(10):785-794. doi: 10.1016/S2213-2600(17)30305-3. Epub 2017 Sep 11.
PubMed 28919201
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
Ghofrani HA, Simonneau G, D'Armini AM, Fedullo P, Howard LS, Jais X, Jenkins DP, Jing ZC, Madani MM, Martin N, Mayer E, Papadakis K, Richard D, Kim NH; MERIT study investigators. Macitentan for the treatment of inoperable chronic thromboembolic pulmonary hypertension (MERIT-1): results from the multicentre, phase 2, randomised, double-blind, placebo-controlled study. Lancet Respir Med. 2024 Apr;12(4):e21-e30. doi: 10.1016/S2213-2600(24)00027-4.
PubMed 38548406

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

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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
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
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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: 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
ClinicalTrials.gov ID: NCT02021292
Acronym / sponsor ID: MERIT-1 / AC-055E201
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: ActelionIndustry (pharma, biotech, devices)
Study start: 20 Aug 2014 (actual)
Primary completion: 28 Sep 2016 (actual)
Study completion: 28 Sep 2016 (actual)
First posted: 27 Dec 2013 (estimated)
Results: Posted 23 Jan 2018

Clinical summary

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Macitentan	Experimental	Drug: MacitentanMacitentan 10 mg, oral tablet, to be taken once daily.
Placebo	Placebo comparator	Drug: PlaceboMatching placebo oral tablet, to be taken once daily.

Who may qualify

Ages: 18 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Written informed consent
Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease).
Female 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 (5 listed)

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.

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 10 mg, oral tablet, to be taken once daily.	Drug	Macitentan
PlaceboMatching placebo oral tablet, to be taken once daily.	Drug	Placebo

Primary outcome

Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.
Time frame: From baseline to Week 16
The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.

3 secondary outcomes

Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).
Time frame: From baseline to Week 24
Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).
Time frame: From baseline to Week 24
Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24
Time frame: From baseline to Week 24

Results and safety

Results posted to the registry on 23 Jan 2018, 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	40	40
Placebo	40	37

Primary outcome: Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.

Time frame: From baseline to Week 16. Geometric mean (95% Confidence Interval). Unit: percent of baseline PVR

Measure	Macitentan n = 40	Placebo n = 40
Value	73.0 (63.6 to 83.8)	87.2 (78.5 to 96.7)

Macitentan vs Placebo: ratio of geometric means: 0.84 (95% CI 0.70 to 0.99), p = 0.0410, ANCOVA

Population analysed: Full analysis set included all subjects assigned to a study treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From double-blind study treatment initiation up to 30 days after study treatment discontinuation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Macitentan	3 of 40 (7.5%)	22 of 40 (55%)	0 of 40
Placebo	7 of 40 (17.5%)	19 of 40 (47.5%)	2 of 40

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.
Results publication: PubMed 28919201Ghofrani HA, Simonneau G, D'Armini AM, Fedullo P, Howard LS, Jais X, Jenkins DP, Jing ZC, Madani MM, Martin N, Mayer E, Papadakis K, Richard D, Kim NH; MERIT study investigators. Macitentan for the treatment of inoperable chronic thromboembolic pulmonary hypertension (MERIT-1): results from the multicentre, phase 2, randomised, double-blind, placebo-controlled study. Lancet Respir Med. 2017 Oct;5(10):785-794. doi: 10.1016/S2213-2600(17)30305-3. Epub 2017 Sep 11.
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.
Derived from this study: PubMed 38548406Ghofrani HA, Simonneau G, D'Armini AM, Fedullo P, Howard LS, Jais X, Jenkins DP, Jing ZC, Madani MM, Martin N, Mayer E, Papadakis K, Richard D, Kim NH; MERIT study investigators. Macitentan for the treatment of inoperable chronic thromboembolic pulmonary hypertension (MERIT-1): results from the multicentre, phase 2, randomised, double-blind, placebo-controlled study. Lancet Respir Med. 2024 Apr;12(4):e21-e30. doi: 10.1016/S2213-2600(24)00027-4.

Related trials for Chronic Thromboembolic Pulmonary Hypertension

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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.

Kelly Papadakis, MD study chair

Actelion

36 sites in 16 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 36 sites in 16 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 5 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 36 sites in China, Russia, France, Germany, Thailand and 11 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. Some participants in this study may receive a placebo. 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 23 Jan 2018). 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?

Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. (time frame: From baseline to Week 16). 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 NCT02021292, which also lists 3 linked publications.

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.