Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (MERIT-2)
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ClinicalTrials.gov Identifier: NCT02060721 |
Recruitment Status :
Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : February 17, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Thromboembolic Pulmonary Hypertension | Drug: Macitentan | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | February 3, 2015 |
Estimated Primary Completion Date : | December 22, 2021 |
Estimated Study Completion Date : | December 22, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Macitentan
Macitentan 10mg, oral tablet, once daily
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Drug: Macitentan
Macitentan 10mg, oral tablet, once daily
Other Name: ACT-064992 |
- Treatment-emergent adverse events (AEs) up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
- AEs leading to premature discontinuation of study drug. [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
- Treatment-emergent serious adverse events up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
- Treatment-emergent marked laboratory abnormalities up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
- Change in vital signs (arterial blood pressure, heart rate) and body weight from baseline to all assessed time points during the study [ Time Frame: From baseline up to 24 months ]
- Change from baseline to each scheduled time point inexercise capacity, as measured by the 6MWD [ Time Frame: Baseline up to 30 months ]
- Change from baseline to each scheduled time point in Borg dyspnea index [ Time Frame: Baseline up to 30 months ]
- Proportion of subjects with worsening of WHO FC from baseline to each scheduled time point. [ Time Frame: Baseline up to 30 months ]
- marked laboratory abnormalities during treatment period and up to 30 days after study drug discontinuation [ Time Frame: From baseline 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 [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060721
Belgium | |
Leuven, Belgium | |
China | |
Beijing, China | |
Guangzhou, China | |
Shanghai, China | |
Shenyang, China | |
Wuhan, China | |
Czechia | |
Praha 2, Czechia | |
France | |
Le Kremlin-Bicetre Cedex, France | |
Paris Cedex 15, France | |
Toulouse Cedex 9, France | |
Germany | |
Giessen, Germany | |
Heidelberg, Germany | |
Würzburg, Germany | |
Hungary | |
Budapest, Hungary | |
Debrecen, Hungary | |
Lithuania | |
Kaunas, Lithuania | |
Mexico | |
Ciudad de Mexico, Mexico | |
Poland | |
Lublin, Poland | |
Wrocław, Poland | |
Russian Federation | |
Kemerovo, Russian Federation | |
Moscow, Russian Federation | |
Novosibirsk, Russian Federation | |
St Petersburg, Russian Federation | |
Tomsk, Russian Federation | |
Switzerland | |
Zürich, Switzerland | |
Thailand | |
Bangkok, Thailand | |
Chiang Mai, Thailand | |
Turkey | |
Capa_Istanbul, Turkey | |
Ukraine | |
Kyiv, Ukraine | |
Lviv, Ukraine | |
United Kingdom | |
Cambridge, United Kingdom | |
London, United Kingdom | |
Sheffield, United Kingdom |
Study Director: | Erin McGuire | Actelion |
Responsible Party: | Actelion |
ClinicalTrials.gov Identifier: | NCT02060721 |
Other Study ID Numbers: |
AC-055E202 2013-003457-25 ( EudraCT Number ) |
First Posted: | February 12, 2014 Key Record Dates |
Last Update Posted: | February 17, 2021 |
Last Verified: | February 2021 |
Chronic thromboembolic pulmonary hypertension (CTEPH) |
Macitentan Hypertension, Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Endothelin A Receptor Antagonists Endothelin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Endothelin B Receptor Antagonists |