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

Phase 4

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: ACT-385781A (Actelion Epoprostenol); Drug: Flolan®

• Registration Number: NCT01105117
• Lead Sponsor: Actelion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Study Start: 2010-05
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Results First Submitted: 2012-07-20
• Results First Submitted QC: 2012-07-20
• Results First Posted: 2012-08-23
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-29
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ACT-385781A (Actelion Epoprostenol)	ACT-385781A (Actelion Epoprostenol)
2	Flolan®	Flolan®

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

University of Colorado - Denver; 🇺🇸 Aurora, Colorado, United States

University of California - San Diego; 🇺🇸 La Jolla, California, United States

Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania-Penn Presybyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States