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TERMINATEDPhase 3NCT01739400

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

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

Lead sponsor: Actelion•5 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Actelion

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

No

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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 16, 2019Terms

Trial snapshot

StatusTERMINATED

PhasePHASE3

Enrollment217

Start dateSep 2013

Last updatedApr 16, 2019

Condition

Pulmonary Arterial Hypertension

Locations shown

Emory University Hospital/the Emory Clinic

Atlanta, Georgia

Barnes-Jewish Hosp/Wash Univ School of Med

St Louis, Missouri

Children'S Heart Center Nevada

Las Vegas, Nevada

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2019Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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