Summary

for people ages 12 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

Official Title

Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension SERAPHIN ACT-064992 Hypertension Familial Primary Pulmonary Hypertension Macitentan

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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 CAN'T join 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.

Locations

  • University of California, San Diego
    La Jolla California 92037-2006 United States
  • Liu Center for Pulmonary Hypertension
    Torrance California 90502 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Actelion
ID
NCT00667823
Phase
Phase 3
Study Type
Interventional
Last Updated