Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (MERIT-2)

• Sponsor: Actelion
• Information provided by (Responsible Party): Actelion

Study Description

Brief 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)

Condition or disease	Intervention/treatment	Phase
Chronic Thromboembolic Pulmonary Hypertension	Drug: Macitentan	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	78 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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)
Actual Study Start Date :	February 9, 2015
Estimated Primary Completion Date :	December 22, 2020
Estimated Study Completion Date :	December 22, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Macitentan; Macitentan 10mg, oral tablet, once daily	Drug: Macitentan; Macitentan 10mg, oral tablet, once daily; Other Name: ACT-064992

Outcome Measures

Primary Outcome Measures :

1. 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) ]
2. 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) ]
3. 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) ]
4. 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) ]
5. 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 ]

Other Outcome Measures:

1. Change from baseline to each scheduled time point inexercise capacity, as measured by the 6MWD [ Time Frame: Baseline up to 30 months ]
2. Change from baseline to each scheduled time point in Borg dyspnea index [ Time Frame: Baseline up to 30 months ]
3. Proportion of subjects with worsening of WHO FC from baseline to each scheduled time point. [ Time Frame: Baseline up to 30 months ]
4. 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. ]
5. 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. ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

  Show 34 Study Locations

Sponsors and Collaborators

Actelion

More Information

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Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT02060721 History of Changes
Other Study ID Numbers:	AC-055E202
First Posted:	February 12, 2014
Last Update Posted:	December 20, 2018
Last Verified:	December 2018

Keywords provided by Actelion:

Chronic thromboembolic pulmonary hypertension (CTEPH)

Additional relevant MeSH terms:

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Macitentan; Hypertension; Hypertension, Pulmonary; 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