Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01470144
• Date of registration: 28/10/2011
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension Epitome2ext
• Scientific title: An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)
• Date of first enrolment: June 1, 2011
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01470144
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, France, Italy, Netherlands, Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed informed consent prior to initiation of any study-mandated procedure

2. Patients who completed participation in study AC-066A301

3. Patients who have not obtained access for commercial EFI at the time of ending
participation in study AC-066A301

Exclusion Criteria:

1. Patients who prematurely discontinued study drug in study AC-066A301

2. Patients for whom continued treatment with EFI is no longer considered appropriate



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Epoprostenol

Primary Outcome(s)

Treatment-emergent Adverse Events [Time Frame: On average 2.72 years]

Secondary Outcome(s)

Exposure Duration [Time Frame: On average 2.72 years]

Secondary ID(s)

AC-066A302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chiltern International Ltd.

Effi-stat

Results

• Results available: Yes
• Date Posted: 09/12/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01470144