Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT02112487
First received: April 8, 2014
Last updated: April 13, 2016
Last verified: April 2016
  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
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: December 2016
Estimated Primary Completion Date: September 2016 (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   (Adult, Senior)
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
Bron Cedex, France, 69677
Hôpital Côte de Nacre
Caen, France, 14033
Hôpital Albert Michallon
Grenoble, France, 38700
CHU de Bicêtre
Le Kremlin-Bicêtre, France, 94270
CHRU Lille - Hôpital Cardiologique
Lille, France, 59037
Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Hôpitaux de Brabois
Nancy, France, 54511
Hôpital de Haut Levêque
Pessac, France, 33604
Hôpital Pontchaillou
Rennes, France, 35033
Hôpital Charles Nicolle
Rouen, France, 76031
Hôpital Nord
Saint-Etienne, France, 42227
Hôpital Civil
Strasbourg, France, 67091
Hôpital Larrey
Toulouse, France, 31059
Italy
Ospedale Sant'Orsola
Bologna, Italy, 40138
A.O.U.C. Careggi
Firenze, Italy, 50124
UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica
Rome, Italy, 00161
Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare
Rome, Italy, 00186
Policlinico G.B. Rossi
Verona, Italy, 37134
Spain
Hospital General de Alicante
Alicante, Spain, 03010
Hospital Val Hebron
Barcelona, Spain, 08035
Hospital Clinic
Barcelona, Spain, 08036
Hospital de Cruces
Bilbao, Spain, 48903
Hospital Reina Sofia
Córdoba, Spain, 14004
Hospital Dr Negrin
Las Palmas de Gran Canaria, Spain, 35010
Hospital Universitario Insular Gran Canarias
Las Palmas de Gran Canaria, Spain, 35016
Hospital 12 Octubre
Madrid, Spain, 28041
Hospital La Paz
Madrid, Spain, 28046
Hospital Carlos Haya
Malaga, Spain, 29010
Hospital Son Espases
Palma de Mallorca, Spain, 7010
Hospital de Valdecilla
Santander, Spain, 39008
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Hospita General U. Valencia
Valencia, Spain, 46014
Sponsors and Collaborators
Actelion
Investigators
Study Director: Loïc Perchene Actelion
  More Information

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: April 13, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica
France: Conseil National de l'Ordre des Médecins
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Committee for the Protection of Personnes

Keywords provided by Actelion:
pulmonary arterial hypertension
PAH-SYMPACT
PAH
psychometric instrument

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists

ClinicalTrials.gov processed this record on September 23, 2016