Clareo Health | Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Actelion
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.
You may not be if
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.
