NCT01105091

Epoprostenol for Injection in Pulmonary Arterial Hypertension

A Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics 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: 30 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and Flolan (epoprostenol sodium) in patients with pulmonary arterial hypertension who are naïve to injectable prostanoid treatment and in need of such treatment. Approximately 30 patients from 8 U.S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2:1 respectively) for 28 days of treatment.

Conditions

• Pulmonary Arterial Hypertension

Interventions

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

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-05-01
• Completion: 2011-07-01
• First posted: 2010-04-16
• Last updated: 2025-02-04
• Results posted: 2012-08-23