Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
Stopped early · Phase 3
Conditions studied: Pulmonary Arterial Hypertension
In brief
Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.
Key facts
- Study ID
- NCT01739400
- Run by
- Actelion
- People needed
- 217
- Starts
- 2013-09-10
- Expected to finish
- 2018-01-12
- Last updated by the study team
- 2019-04-16
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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).
Where it is running
- Barnes-Jewish Hosp/Wash Univ School of Med — St Louis, Missouri, United States
- Children'S Heart Center Nevada — Las Vegas, Nevada, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Texas Children'S Hosp - Dept of Cardiology — Houston, Texas, United States
- Gen Hosp Univ Vienna Dept Cardiology — Vienna, Austria
- Mhat Nat Card Hosp - Cardiology Clinic — Sofia, Bulgaria
- Mhat Nat Card Hosp - Pediatric Clin / Ped Card Dept — Sofia, Bulgaria
- Mhat Sveta Anna Clin Card — Sofia, Bulgaria
- Instituto Nacional del Torax — Providencia, Santiago RCH, Chile
- Clinica Tabancura - Cardio Unit — Santiago, Chile
- Guangdong General Hospital, Cardiology Dpt — Guangzhou, Guangdong, China
- Wu Han Asia Heart Hosp — Wuhan, Hubei, China
- The General Hosp of Shenyang Military Region — Shenyang, Liaoning, China
- Beijing Anzhen Hospital, Cardiology Dpt — Beijing, China
- Cardiovascular Institute&Fuwai Hospital — Beijing, China
- Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation — Shanghai, China
- Hosp La Timone - Dept Pediatric Cardiology — Marseille, France
- Hosp Laennec - Dept Cardiology — Nantes, France
- Hosp Pompidou - Dept Congenital Cardiac Diseases — Paris, France
- Hosp Cardiology Haut Leveque - Dept Congenital Diseases — Pessac, France
- Herzzentrum Berlin, Ped Cardiology — Berlin, Germany
- Universitätsklinikum Giessen - Pediatric Heart Center — Giessen, Germany
- Uni Heidelberg - Kinderkardiologie — Heidelberg, Germany
- Ahepa University General Hospital — Thessaloniki, Greece
- Emory University Hospital/the Emory Clinic — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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