Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT02112487
First received: April 8, 2014
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
PAH
Drug: Macitentan
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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™

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study. [ Time Frame: Baseline to end of treatment visit (around 6 months on average) ] [ Designated as safety issue: Yes ]
    • Treatment-emergent adverse events (AEs)
    • AEs leading to premature discontinuation of study drug
    • Treatment-emergent serious adverse events (SAEs)
    • Proportion of patients with treatment-emergent ALT and/or AST abnormality (> 3, > 5, and > 8 x ULN) associated or not with total bilirubin > 2 x ULN.
    • Proportion of patients with treatment-emergent hemoglobin abnormality (≦ 100 g/L, and ≦ 80 g/L)


Estimated Enrollment: 160
Study Start Date: June 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macitentan
10 mg once daily
Drug: Macitentan
10 mg once daily
Other Name: ACT-064992

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112487

Locations
France
Hôpital Louis Pradel Recruiting
Bron Cedex, France, 69677
Contact: Vincent Cottin    33472357072    vincent.cottin@chu-lyon.fr   
Hôpital Côte de Nacre Recruiting
Caen, France, 14033
Contact: Emanuel Bergot    33 2 31064677    bergot-e@chu-caen.fr   
Hôpital Albert Michallon Recruiting
Grenoble, France, 38700
Contact: Christophe Pison    +33-4-76765834    cpison@chu-grenoble.fr   
CHU de Bicêtre Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Laurent Savale    33145217991    laurent.savale@gmail.com   
CHRU Lille - Hôpital Cardiologique Recruiting
Lille, France, 59037
Contact: Pascal deGroote    33 3 20 44 57 21    pascal.degroote@chru-lille.fr   
Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Contact: Arnaud Bourdin    +33 4 67 33 60 91    arnaud01009157@gmail.com   
Hôpitaux de Brabois Recruiting
Nancy, France, 54511
Contact: Jean-Francois Chabot    +33-3-83154021    f.chabot@chu-nancy.fr   
Hôpital de Haut Levêque Recruiting
Pessac, France, 33604
Contact: Claire Dromer    33557656189    claire.dromer@chu-bordeaux.fr   
Hôpital Pontchaillou Recruiting
Rennes, France, 35033
Contact: Celine Chabanne    +33-2-99282519    celine.chabanne@chu-rennes.fr   
Hôpital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: Fabrice Bauer    +33-2-32888232    fabrice.bauer@chu-rouen.fr   
Hôpital Nord Recruiting
Saint-Etienne, France, 42227
Contact: Laurent Bertoletti    +33-4-77127770    laurent.bertoletti@gmail.com   
Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Matthieu Canuet    33 3 6955 0645    matthieu.canuet@chru-strasbourg.fr   
Hôpital Larrey Recruiting
Toulouse, France, 31059
Contact: Gregoire Prevot    335677717 09    prevot.g@chu-toulouse.fr   
Spain
Hospital Val Hebron Recruiting
Barcelona, Spain, 08035
Contact: Manuel Lopez Meseguer    34932746000; Ext: 6208    manuelop@vhebron.net   
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Joan Albert Barberà Mir    34932275747    jbarbera@clinic.ub.es   
Hospital Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: Francisco Santos Luna    34957010411    fsantos1957@hotmail.com   
Hospital Universitario Insular Gran Canarias Recruiting
Las Palmas de Gran Canaria, Spain, 35016
Contact: Francisco Javier Guerra    34654451489    fcojavguerra@hotmail.com   
Hospital La Paz Recruiting
Madrid, Spain, 28046
Contact: Juan Jose Rios Blanco    34630064677    juanjo.rios@gmail.com   
Hospital 12 Octubre Recruiting
Madrid, Spain, 28041
Contact: Pilar Escribano    34913908669    pilar.escribano@telefonica.net   
Hospital Carlos Haya Recruiting
Malaga, Spain, 29010
Contact: Enrique de Ramón    34630373364    ederamongm2@gmail.com   
Hospital Son Espases Recruiting
Palma de Mallorca, Spain, 7010
Contact: Ernest Sala Llinas    34871 206507 ext 76507    Ernest.sala@ssib.es   
Hospital de Valdecilla Recruiting
Santander, Spain, 39008
Contact: José Cifrián Martinez    34696 859 471    jmcifrian@humv.es   
Hospital Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Remedios Otero Candelera    34955013172    rotero@separ.es   
Hospita General U. Valencia Recruiting
Valencia, Spain, 46014
Contact: Gustavo Juan Samper    34961972230    Gustavo.Juan@uv.es   
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02112487     History of Changes
Other Study ID Numbers: AC-055-311
Study First Received: April 8, 2014
Last Updated: August 11, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Keywords provided by Actelion:
pulmonary arterial hypertension
PAH

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2014