TerminatedPhase 3

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

Stopped: Primary endpoint of parent study AC-055-305/MAESTRO (NCT01743001) not met.

United States, Austria, Bulgaria217 participantsStarted 2013-09-10

Plain-language summary

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12

Timeframe: 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

Timeframe: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.

Change in Borg Dyspnea Score at Month 6 and 12

Timeframe: 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

Timeframe: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.

Trial details

NCT IDNCT01739400

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01-12

Results submitted2019-01-09

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12

Timeframe: 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

Timeframe: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.

Change in Borg Dyspnea Score at Month 6 and 12

Timeframe: 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

Timeframe: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.