Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertensio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

Signed informed consent prior to initiation of any study-mandated procedure.
• Patients with pulmonary arterial hypertension and having completed the event-driven study,
AC-055-302/SERAPHIN, or
Patients who have experienced a morbidity event and for whom a written approval to roll
over into this study has been obtained from the Sponsor.
• Men or women = 12 years of age:
Only sites that have adequate pediatric pulmonary experience are allowed to enroll
patients between 12 and 17 year of age.
• Women of childbearing potential* with a negative pre-treatment serum
pregnancy test and who consistently and correctly use (from screening and up to
28 days after study treatment discontinuation) a reliable method of contraception
with a Pearl index of < 1% (oral hormonal contraceptive, implant, vaginal
hormone ring, or intrauterine system [IUS]). During the entire study duration
and for at least 1 month after last study drug intake, your partner, if not
vasectomised, must use a condom in addition.
*A woman is considered to have childbearing potential unless she meets at least one of
the following criteria:
- previous bilateral salpingo-oophorectomy or hysterectomy,
- premature ovarian failure confirmed by a specialist gynecologist,
- pre-pubescence, XY genotype, Turner syndrome, uterine agenesis,
- age > 50 years and not treated with any kind of HRT for at least 2 years
prior to screening with amenorrhea for at least 24 consecutive months
prior to screening and a serum FSH level of > 40 IU/L at screening.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 513
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79

Exclusion Criteria

•Any major violation of protocol AC-055-302/SERAPHIN.
•Pregnancy or breast-feeding.
•AST and/or ALT > 3 times the upper limit of the normal range.
•Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
•Known hypersensitivity to ACT-064992 or any of the excipients.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension (PAH).;Secondary Objective: N/A;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A

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