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

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)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: ACT-385781A (Actelion Epoprostenol); Drug: Flolan®

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California - San Diego
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado - Denver
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania-Penn Presybyterian Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; ACT-385781A (Actelion Epoprostenol)	Drug: ACT-385781A (Actelion Epoprostenol); per Prescribing Information
Active Comparator: 2; Flolan®	Drug: Flolan®; per Prescribing Information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Actelion
• Investigators: Study Director: Wade Benton, PharmD, Actelion

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Pulmonary Arterial Hypertension; PAH; EPITOME-1
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Antihypertensive Agents; Vasodilator Agents; Platelet Aggregation Inhibitors; Epoprostenol; Tezosentan
• Other Study ID Numbers: AC-066A402