An extension of the ORCHESTRA (AC-055-310) study Extension del estudio ORCHESTRA (AC-055-310)

• Register: EUCTR
• Last refreshed on: 15 October 2018
• Main ID: EUCTR2013-003489-15-ES
• Date of registration: 27/12/2013
• Prospective Registration: Yes
• Primary sponsor: ACTELION Pharmaceuticals Ltd.
• Public title: An extension of the ORCHESTRA (AC-055-310) study Extension del estudio ORCHESTRA (AC-055-310)
• Scientific 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™ - ORCHESTRA Ext.
• Date of first enrolment: 20/02/2014
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003489-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Italy, Spain

Contacts

• Name: Global Medical Information
• Affiliation: ACTELION Pharmaceuticals Ltd.

• Name: Global Medical Information
• Affiliation: ACTELION Pharmaceuticals Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
? Signed informed consent prior to any study-mandated procedure.
? Patients with PAH who completed the ORCHESTRA study (AC-055-310) as scheduled.
? Women of childbearing potential 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
? Patients who prematurely discontinued study drug in the ORCHESTRA study (AC-055-310).
? Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study.
? Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Pulmonary arterial hypertension
MedDRA version: 16.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: macitentan
Product Code: ACT-064992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

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

Primary end point(s): Safety endpoints
? Treatment-emergent adverse events (AEs)1
? 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 × ULN) associated or not with total bilirubin > 2 × ULN, up to EOT.
? Proportion of patients with treatment-emergent hemoglobin abnormality (? 100 g/L, and ? 80 g/L), up to EOT.

Timepoint(s) of evaluation of this end point: Monthly laboratory test and 6-Monthly visit

Secondary Objective: N/A

Secondary Outcome(s)

Secondary end point(s): N/A

Timepoint(s) of evaluation of this end point: N/A

Secondary ID(s)

2013-003489-15-IT

AC-055-311

Source(s) of Monetary Support

ACTELION Pharmaceuticals Ltd.