Summary

for people ages 18 years and up (full criteria)
at UCSD UC Davis
study started
estimated completion:

Description

Summary

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

Official Title

Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of Selexipag (ACT-293987) in Patients With Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension Open-label PAH Hypertension Familial Primary Pulmonary Hypertension Selexipag ACT-293987

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients who participated to the double-blind study AC-065A302 and either had a morbidity event or had completed the study as scheduled per protocol.
  • Signed informed consent.

You CAN'T join if...

  • Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.
  • Severe hepatic impairment (Child-Pugh C).
  • Females who are pregnant or who plan to become pregnant during the study, or are breastfeeding.
  • 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.

Locations

  • University of California San Diego Medical Center (La Jolla)
    La Jolla California 92093-0052 United States
  • University of California, Davis, UC Davis Medical Center
    Sacramento California 95817 United States
  • GLVA Healthcare Center
    Los Angeles California 90073 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Actelion
ID
NCT01112306
Phase
Phase 3
Study Type
Interventional
Last Updated