NCT01470144

Brief Summary

This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2011

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 9, 2016

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

4 years

First QC Date

October 28, 2011

Results QC Date

October 18, 2016

Last Update Submit

January 31, 2025

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Treatment-emergent Adverse Events

    On average 2.72 years

Secondary Outcomes (1)

  • Exposure Duration

    On average 2.72 years

Study Arms (1)

Treatment

EXPERIMENTAL

Single arm, open-label

Drug: Epoprostenol

Interventions

EpoprostenolDRUG

Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent prior to initiation of any study-mandated procedure
  • Patients who completed participation in study AC-066A301
  • Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301

You may not qualify if:

  • Patients who prematurely discontinued study drug in study AC-066A301
  • Patients for whom continued treatment with EFI is no longer considered appropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Epoprostenol

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins IProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Thomas Pfister, PhD
Organization
Actelion Pharmaceuticals Ltd
thomas.pfister@actelion.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2011

First Posted

November 11, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

February 4, 2025

Results First Posted

December 9, 2016

Record last verified: 2025-01