Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01739400
• Date of registration: 29/11/2012
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome MAESTRO-OL
• Scientific title: Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
• Date of first enrolment: September 10, 2013
• Target sample size: 217
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01739400
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States, Vietnam

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects with ES (including those with Down Syndrome) having completed the double-blind
AC-055-305 / MAESTRO study as scheduled, i.e., who remained in the double-blind study up to
Week 16 (whether or not they were still taking study drug at the end of this period).

Exclusion Criteria:

Subjects who prematurely discontinue double-blind study drug during the AC-055-305 /
MAESTRO study due to:

- an AE assessed as related to the use of study drug,

- or elevated liver tests (related or unrelated to study drug).



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Macitentan 10 mg tablet, once daily.

Primary Outcome(s)

Change in Borg Dyspnea Score at Month 6 and 12 [Time Frame: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.]

Change in WHO Functional Class (FC) at Month 6 and 12 [Time Frame: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.]

Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12 [Time Frame: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.]

Change in Peripheral Oxygen Saturation (SpO2) at Rest at Month 6 and 12 [Time Frame: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.]

Secondary ID(s)

AC-055-308

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01739400