Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
NCT ID: NCT02112487
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2014-06-23
2018-09-19
Brief Summary
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To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Macitentan
10 mg once daily
Macitentan
10 mg once daily
Interventions
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Macitentan
10 mg once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with PAH who completed the ORCHESTRA study (AC-055-310) as scheduled
3. Women of childbearing potential (as defined below) must:
* Have a negative serum pregnancy test at Visit 1 (i.e., Visit 4 of study AC 055 310) and agree to perform monthly serum pregnancy tests.
* Agree to use two reliable methods of contraception in parallel, from Visit 1 until 1 month after study drug discontinuation (see details below).
* A female is considered to have childbearing potential unless she meets at least one of the following criteria:
* Previous bilateral salpingo and/or oophorectomy, or hysterectomy.
* Premature ovarian failure confirmed by a specialist.
* Pre-pubescence, XY genotype, Turner syndrome, uterine agenesis.
* Postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause.
* Of the two contraceptive methods that must be used, one must be from Group 1, and one must be from Group 2, defined as follows:
* Group 1: Oral, implantable, transdermal or injectable hormonal contraceptives, intrauterine devices, female sterilization (tubal ligation or non-surgical sterilization, e.g., permanent contraception with Essure procedure), or partner's sterilization (vasectomy). If a hormonal contraceptive is chosen from this group, it must be taken for at least one month prior to enrollment. Alternatively, if the Essure procedure is chosen as a contraceptive method, a hysterosalpingogram must have been performed to confirm correct location of the microinserts and tubal occlusion (as per manufacturer's recommendations).
* Group 2: Female or male condoms, diaphragm or cervical cap, any of them in combination with a spermicide.
* Sexual abstinence, rhythm methods, or contraception by the partner alone are not considered as acceptable methods of contraception for this study.
Exclusion Criteria
2. Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study.
3. AST and/or ALT more than 3 X ULN.
18 Years
80 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Loïc Perchenet
Role: STUDY_DIRECTOR
Actelion
Locations
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Hôpital Louis Pradel
Bron, , France
Hôpital Côte de Nacre
Caen, , France
Hôpital Albert Michallon
Grenoble, , France
CHU de Bicêtre
Le Kremlin-Bicêtre, , France
CHRU Lille - Hôpital Cardiologique
Lille, , France
Hôpital Arnaud de Villeneuve
Montpellier, , France
Hôpitaux de Brabois
Nancy, , France
Hôpital de Haut Levêque
Pessac, , France
Hôpital Pontchaillou
Rennes, , France
Hôpital Charles Nicolle
Rouen, , France
Hôpital Nord
Saint-Etienne, , France
Hôpital Civil
Strasbourg, , France
Hôpital Larrey
Toulouse, , France
Ospedale Sant'Orsola
Bologna, , Italy
A.O.U.C. Careggi
Florence, , Italy
UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica
Rome, , Italy
Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare
Rome, , Italy
Policlinico G.B. Rossi
Verona, , Italy
Hospital General de Alicante
Alicante, , Spain
Hospital Val Hebron
Barcelona, , Spain
Hospital Clinic
Barcelona, , Spain
Hospital de Cruces
Bilbao, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital Dr Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Insular Gran Canarias
Las Palmas de Gran Canaria, , Spain
Hospital 12 Octubre
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Carlos Haya
Málaga, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Hospital de Valdecilla
Santander, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Hospita General U. Valencia
Valencia, , Spain
Countries
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Related Links
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Extension of the psychometric validation study ORCHESTRA in patients with PAH
Other Identifiers
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AC-055-311
Identifier Type: -
Identifier Source: org_study_id
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