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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02021292
• Date of registration: 20/12/2013
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension MERIT-1
• Scientific 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
• Date of first enrolment: August 20, 2014
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02021292
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Lithuania, Mexico, Netherlands, Poland, Russian Federation, South Africa, Switzerland, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam

Contacts

• Name: Kelly Papadakis, MD
• Affiliation: Actelion

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 84 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Thromboembolic Pulmonary Hypertension

Intervention(s)

Drug: Placebo

Drug: Macitentan

Primary Outcome(s)

Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. [Time Frame: From baseline to Week 16]

Secondary Outcome(s)

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]

Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24 [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]

Secondary ID(s)

AC-055E201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/01/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02021292