This trial has been completed.

Condition chronic thromboembolic pulmonary hypertension
Treatments macitentan, placebo
Phase phase 2
Sponsor Actelion
Start date August 2014
End date September 2016
Trial size 78 participants
Trial identifier NCT02021292, AC-055E201


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Macitentan 10 mg, oral tablet, to be taken once daily.
macitentan ACT-064992
Macitentan 10 mg, oral tablet, to be taken once daily.
(Placebo Comparator)
Matching placebo oral tablet, to be taken once daily.
Matching placebo oral tablet, to be taken once daily.

Primary Outcomes

Pulmonary vascular resistance (PVR) at rest at Week 16 expressed as percent of baseline PVR at rest
time frame: baseline to Week 16

Secondary Outcomes

Change from baseline to Week 24 in exercise capacity, as measured by the 6-minute walk distance (6MWD).
time frame: 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: baseline to Week 24
Proportion of subjects with worsening in WHO functional class from baseline to Week 24
time frame: baseline to Week 24

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Actelion.