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 States217 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 range12 Years

SexALL

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).

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 range12 Years

SexALL

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.