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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01470144
Recruitment Status : Completed
First Posted : November 11, 2011
Results First Posted : December 9, 2016
Last Update Posted : June 26, 2017
Chiltern International Ltd.
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: Epoprostenol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Extension study for patients who completed EPITOME-2 (AC-066A301). Patients continued to receive EFI (epoprostenol sodium). In 6 countries (FR, CA, BE, NL, IT, ES) at 8 expert centers for the treatment of patients with pulmonary arterial hypertension. Recruitment started on 15 June 2011 and was completed on 02 February 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Treatment All patients who received at least one dose of EFI

Participant Flow:   Overall Study
COMPLETED   31 [1] 
Adverse Event                2 
Death                1 
Lung transplant                6 
Patient’s and investigator’s decision                1 
[1] "Completed" corresponds to subjects switching to commercial EFI upon market approval/reimbursement

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Treatment All patients who received at least one dose of EFI

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (23 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      30  73.2% 
Male      11  26.8% 

  Outcome Measures

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

2.  Secondary:   Exposure Duration   [ Time Frame: On average 2.72 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Thomas Pfister, PhD
Organization: Actelion Pharmaceuticals Ltd

Responsible Party: Actelion Identifier: NCT01470144     History of Changes
Other Study ID Numbers: AC-066A302
First Submitted: October 28, 2011
First Posted: November 11, 2011
Results First Submitted: October 18, 2016
Results First Posted: December 9, 2016
Last Update Posted: June 26, 2017