None listed
Conditions
Interventions
AC-064992 Type of group
The tablet of the study drug, 10 mg AC-064992, will be taken orally once a day, regardless of food intake. Patients will receive a new medication kit every 6 months until the end of study AC-055-303 / SERAPHIN OL.
Sponsors
Actelion Pharmaceuticals Ltd,
Eligibility
Sex/Gender
All
Age
12 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Signed informed consent before initiating any procedure specific to the study. • Patients with symptomatic pulmonary arterial hypertension and who have concluded the study activated by event, AC-055-302 / SERAPHIN, or patients who have suffered a morbidity and in which a written approval to enter the study has been obtained from the sponsor • Pregnancy - Not allowed during the study: The participation of women with pregnancy potential is allowed with a negative test of pregnancy in serum before treatment, using correctly and consistently (from the selection and up to 28 days after the suspension) of treatment) a reliable contraceptive method with a Pearl index <1% (oral hormonal contraceptive, implant, hormonal vaginal ring or intrauterine device, who abstain sexually or have a sexual partner with vasectomy.
Exclusion criteria
Exclusion criteria: • Any major violation of the AC-055-302 / SERAPHIN protocol. • Pregnancy or breastfeeding. • AST and / or ALT> 3 times the upper limit of the normal range. • Any known factor or disease that could interfere with adherence to treatment, conduct of study or interpretation of results, such as dependence on a drug or alcohol, or psychiatric illness. • Known hypersensitivity to ACT-064992 or any of its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:An adverse event (AE) is any adverse change in the patients baseline condition, that is, any unfavorable and unpremeditated sign, including an abnormal laboratory finding, symptom or disease, that occurs during the course of the study, whether or not considered related to the study drug. Measure:Adverse events arising from treatment up to 28 days after the suspension of the study drug. Timepoints:28 days after the suspension of the study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A serious adverse event (SAE) is defined by the guidelines of the International Conference on Harmonization (ICH) as an AE that meets at least one of the following criteria: Fatal, puts life at risk, requires hospitalization or prolongation of hospitalization existing, results in a persistent or significant disability or disability, congenital anomaly or birth defect, medically significant or requires intervention to prevent at least one of the above-mentioned results. Measure:SAEs emerging from treatment up to 28 days after the suspension of the study drug Timepoints:28 days after the suspension of the study drug ; Outcome name:An adverse event (AE) is any adverse change in the patients baseline condition, that is, any unfavorable and unpremeditated sign, including an abnormal laboratory finding, symptom or disease, that occurs during the course of the study, whether or not considered related to the study drug. Measure:AEs that cause the premature suspension of the study drug Timepoints:During the study ; Outcome name:Increases that are outside the following ranges:> 3y 5 and 8 X ULN Measure:Increases in ALT and / or AST arising from treatment up to 28 days after the suspension of the study drug Timepoints:28 days after the suspension of the study drug ; Outcome name:Abnormalities outside the following ranges: 8 and <10 g / dl Measure:Abnormalities in hemoglobin emerging from treatment up to 28 days after stopping the study drug Timepoints:28 days after stopping the study drug | — |
Countries
India, Peru, Thailand
Contacts
Public ContactFelix Medina
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed