Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension (Epitome2ext)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Actelion

ClinicalTrials.gov Identifier:

NCT01470144

First received: October 28, 2011

Last updated: March 14, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 28, 2011
Last Updated Date	March 14, 2013
Start Date ^ICMJE	June 2011
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 9, 2011)	treatment-emergent adverse events [ Time Frame: up to 24 hours post trial ] [ Designated as safety issue: Yes ] treatment-emergent adverse events up to 24 hours post end of trial
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01470144 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 9, 2011)	adverse events [ Time Frame: Baseline to end of study (3 months) ] [ Designated as safety issue: Yes ] safety endpoint of adverse events leading to premature discontinuation of study drug
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
Official Title ^ICMJE	An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pulmonary Arterial Hypertension
Intervention ^ICMJE	Drug: Epoprostenol 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.
Study Arm (s)	Experimental: epopropstenol Intervention: Drug: Epoprostenol
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	41
Estimated Completion Date	April 2014
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: Patients who prematurely discontinued study drug in study AC-066A301 Patients for whom continued treatment with EFI is no longer considered appropriate
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium, Canada

Administrative Information
NCT Number ^ICMJE	NCT01470144
Other Study ID Numbers ^ICMJE	AC-066A302
Has Data Monitoring Committee	No
Responsible Party	Actelion
Study Sponsor ^ICMJE	Actelion
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Actelion
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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