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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ACT-385781A (Actelion Epoprostenol)
Flolan®
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary Arterial Hypertension, PAH, EPITOME-1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California - San Diego
  • University of Colorado - Denver
  • Duke University Medical Center
  • University of Pennsylvania-Penn Presybyterian Medical Center
  • Vanderbilt Medical Center
  • University of Texas Southwestern Medical Center
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

ACT-385781A (Actelion Epoprostenol)

Flolan®

Outcomes

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
Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths

Secondary Outcome Measures

Full Information

First Posted
April 15, 2010
Last Updated
November 29, 2012
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT01105117
Brief Title
Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Pulmonary Arterial Hypertension, PAH, EPITOME-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
ACT-385781A (Actelion Epoprostenol)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Flolan®
Intervention Type
Drug
Intervention Name(s)
ACT-385781A (Actelion Epoprostenol)
Intervention Description
per Prescribing Information
Intervention Type
Drug
Intervention Name(s)
Flolan®
Intervention Description
per Prescribing Information
Primary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to initiation of any study-mandated procedure Patients who completed participation in study AC-066A401 Patients who have not obtained authorization for commercial ACT-385781 and Flolan at the time of ending participation in study AC-066A401 Exclusion Criteria: Patients who prematurely discontinued study drug in study AC-066A401 Patients for whom continued treatment with either ACT-385781 and Flolan is no longer considered appropriate Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients 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 Known concomitant life-threatening disease with a life expectancy < 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wade Benton, PharmD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
University of California - San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Colorado - Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Pennsylvania-Penn Presybyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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