Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 (EPITOME-1 Ext)

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 15, 2010
Last updated: November 29, 2012
Last verified: November 2012
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.

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: ACT-385781A (Actelion Epoprostenol)
Drug: Flolan®
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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 [ Time Frame: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication ] [ Designated as safety issue: Yes ]
  • Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths [ Time Frame: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ACT-385781A (Actelion Epoprostenol)
Drug: ACT-385781A (Actelion Epoprostenol)
per Prescribing Information
Active Comparator: 2
Drug: Flolan®
per Prescribing Information


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105117

United States, California
University of California - San Diego
La Jolla, California, United States, 92037
United States, Colorado
University of Colorado - Denver
Aurora, Colorado, United States, 80045
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania-Penn Presybyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Study Director: Wade Benton, PharmD Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01105117     History of Changes
Other Study ID Numbers: AC-066A402 
Study First Received: April 15, 2010
Results First Received: July 20, 2012
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 04, 2016