Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 (EPITOME-1 Ext)
This study has been completed.
Sponsor:
Actelion
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01105117
First received: April 15, 2010
Last updated: November 29, 2012
Last verified: November 2012
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Purpose
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:
Genetics Home Reference related topics:
pulmonary arterial hypertension
MedlinePlus related topics:
High Blood Pressure
U.S. FDA Resources
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
Flolan®
|
Drug: Flolan®
per Prescribing Information
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105117
Locations
| 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
Actelion
Investigators
| 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 PAH EPITOME-1 |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Epoprostenol Tezosentan |
Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on June 18, 2013