Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401

Pulmonary Arterial Hypertension Clinical Trial

— EPITOME-1 Ext  

Official title:

An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105117
• Other study ID #: AC-066A402
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2010
• Last updated: November 29, 2012
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

2. Patients who completed participation in study AC-066A401

3. Patients who have not obtained authorization for commercial ACT-385781 and Flolan at the time of ending participation in study AC-066A401

Exclusion Criteria:

1. Patients who prematurely discontinued study drug in study AC-066A401

2. Patients for whom continued treatment with either ACT-385781 and Flolan is no longer considered appropriate

3. Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients

4. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease

5. Known concomitant life-threatening disease with a life expectancy < 12 months

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• ACT-385781A (Actelion Epoprostenol)
per Prescribing Information
• Flolan®
per Prescribing Information

Locations

Country	Name	City	State
United States	University of Colorado - Denver	Aurora	Colorado
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	University of California - San Diego	La Jolla	California
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	University of Pennsylvania-Penn Presybyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment		Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication	Yes
Primary	Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths		Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication	Yes