Clinical trial NCT02112487: Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
Official title: An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension
PAH-SYMPACT
PAH
psychometric instrument
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH.

To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

Detailed description: To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure.
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:

1. Patients who prematurely discontinued study drug in study AC-055-310.
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.

Primary outcomes:
measure: To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
timeFrame: Baseline to end of treatment visit (around 6 months on average)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron Cedex
country: France
facility: Hôpital Louis Pradel
city: Caen
country: France
facility: Hôpital Côte de Nacre
city: Grenoble
country: France
facility: Hôpital Albert Michallon
city: Le Kremlin-Bicêtre
country: France
facility: CHU de Bicêtre
city: Lille
country: France
facility: CHRU Lille - Hôpital Cardiologique
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nancy
country: France
facility: Hôpitaux de Brabois
city: Pessac
country: France
facility: Hôpital de Haut Levêque
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint-Etienne
country: France
facility: Hôpital Nord
city: Strasbourg
country: France
facility: Hôpital Civil
city: Toulouse
country: France
facility: Hôpital Larrey
city: Bologna
country: Italy
facility: Ospedale Sant'Orsola
city: Firenze
country: Italy
facility: A.O.U.C. Careggi
city: Rome
country: Italy
facility: UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica
city: Rome
country: Italy
facility: Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare
city: Verona
country: Italy
facility: Policlinico G.B. Rossi
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Val Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Dr Negrin
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular Gran Canarias
city: Madrid
country: Spain
facility: Hospital 12 Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Santander
country: Spain
facility: Hospital de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospita General U. Valencia
Study officials:
affiliation: Actelion
name: Loïc Perchenet
role: STUDY_DIRECTOR
References: