NCT01105117

Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401

An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	ACT-385781A (Actelion Epoprostenol)	per Prescribing Information
DRUG	Flolan®	per Prescribing Information

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-07-01
• Completion: 2011-12-01
• First posted: 2010-04-16
• Last updated: 2012-12-03
• Results posted: 2012-08-23

Locations

7 sites across 1 country: United States