Clinical trial NCT01739400: Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: Eisenmenger Syndrome
exercise capacity
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 217
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
measure: 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.
measure: 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.
measure: 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.
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/the Emory Clinic
state: Georgia
city: Saint Louis
country: United States
facility: Barnes-Jewish Hosp/Wash Univ School of Med
state: Missouri
city: Las Vegas
country: United States
facility: Children'S Heart Center Nevada
state: Nevada
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Houston
country: United States
facility: Texas Children'S Hosp - Dept of Cardiology
state: Texas
city: Vienna
country: Austria
facility: Gen Hosp Univ Vienna Dept Cardiology
city: Sofia
country: Bulgaria
facility: Mhat Nat Card Hosp - Cardiology Clinic
city: Sofia
country: Bulgaria
facility: Mhat Nat Card Hosp - Pediatric Clin / Ped Card Dept
city: Sofia
country: Bulgaria
facility: Mhat Sveta Anna Clin Card
city: Providencia
country: Chile
facility: Instituto Nacional del Torax
state: Santiago RCH
city: Santiago
country: Chile
facility: Clinica Tabancura - Cardio Unit
city: Guangzhou
country: China
facility: Guangdong General Hospital, Cardiology Dpt
state: Guangdong
city: Wuhan
country: China
facility: Wu Han Asia Heart Hosp
state: Hubei
city: Shenyang
country: China
facility: The General Hosp of Shenyang Military Region
state: Liaoning
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Cardiology Dpt
city: Beijing
country: China
facility: Cardiovascular Institute&Fuwai Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation
city: Marseille Cedex 5
country: France
facility: Hosp La Timone - Dept Pediatric Cardiology
city: Nantes Cedex 1
country: France
facility: Hosp Laennec - Dept Cardiology
city: Paris cedex 15
country: France
facility: Hosp Pompidou - Dept Congenital Cardiac Diseases
city: Pessac
country: France
facility: Hosp Cardiology Haut Leveque - Dept Congenital Diseases
city: Berlin
country: Germany
facility: Herzzentrum Berlin, Ped Cardiology
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen - Pediatric Heart Center
city: Heidelberg
country: Germany
facility: Uni Heidelberg - Kinderkardiologie
city: Thessaloniki
country: Greece
facility: Ahepa University General Hospital
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clin En Med, Sc (Udicem)
state: Nuevo Leon
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiologia (Inc) Ignacio Chavez
city: Querétaro
country: Mexico
facility: Instituto de Corazon de Querètaro
city: Manila
country: Philippines
facility: PHC, MAB
city: Gdańsk
country: Poland
facility: Cardiology Gdańsk Univ
city: Krakow
country: Poland
facility: Cardiology Kraków Univ
city: Wrocław
country: Poland
facility: Cardiology Wrocław
city: Coimbra
country: Portugal
facility: Hosp Univ Coimbra - Dpt Cardiology
city: Lisboa
country: Portugal
facility: Hosp Sta Marta - Dept Cardiology
city: Bucaresti
country: Romania
facility: Er Inst For Cardvasc Dis "Prof Dr Cc Iliescu" - Card Ii
city: Targu-Mures
country: Romania
facility: Cardio Med Srl
city: Timisoara
country: Romania
facility: Clin Hosp For Inf and Pulm Dis Victor Babes - Ii Pulm
city: Kemerovo
country: Russian Federation
facility: Sci Institute Systemic Poriblems Cardio Diseases Kemerovo
city: Moscow
country: Russian Federation
facility: Russian Cardiology Scientific and Production Complex
city: St Petersburg
country: Russian Federation
facility: V. A. Almazov Institute of Cardiology
city: Belgrade
country: Serbia
facility: Dedinje Cardiovasc Inst - Cardiovasc Research Ctr
city: Belgrade
country: Serbia
facility: Mother and Child Health Care Institute Dr. Vukan Cupic
city: Belgrade
country: Serbia
facility: Clin Hosp Ctr Zemun - Cardiology Dept
city: Barcelona
country: Spain
facility: Hosp Univ Vall D'Hebron - Dpt Congenital Heart Disease Adult
city: Sevilla
country: Spain
facility: Hosp Univ Virgen Macarena - Dpt Cardiology
city: Valencia
country: Spain
facility: Hosp Universitario La Fe Dpt Cardiology
city: Bristol
country: United Kingdom
facility: Bristol Univ Hosp Congenital Heart Centre
city: Hanoi
country: Vietnam
facility: Hanoi Medical University Hospital
city: Ho Chi Minh
country: Vietnam
facility: Children'S Hospital, Ho Chi Minh
city: Ho Chi Minh
country: Vietnam
facility: Tam Duc Hospital
Study officials:
References: