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Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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)

NCT01105117•Actelion

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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

Locations (7)

University of California - San Diego

La Jolla, California, United States

University of Colorado - Denver

Aurora, Colorado, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Pennsylvania-Penn Presybyterian Medical Center

Philadelphia, Pennsylvania, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

July 1, 2011

Completion Date

December 1, 2011

Last Updated

December 3, 2012

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

ACT-385781A (Actelion Epoprostenol)

DRUG

Flolan®

DRUG

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1/PHASE2

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization