Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02112487
• Date of registration: 08/04/2014
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
• 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™
• Date of first enrolment: June 23, 2014
• Target sample size: 88
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02112487
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France, Italy, Spain

Contacts

• Name: Loïc Perchenet
• Affiliation: Actelion

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Macitentan

Primary Outcome(s)

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)]

Secondary ID(s)

AC-055-311

Source(s) of Monetary Support

Please refer to primary and secondary sponsors