Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Macitentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02112487

AC-055-311

Details and patient eligibility

About

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.

Full description

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

Enrollment: 88 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Macitentan

Experimental group

Description:

10 mg once daily

Treatment:

Drug: Macitentan