Pulmonary Arterial HypertensionPhase 4EPITOME-1 ExtNCT01105117
Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
A Phase 4 study testing ACT-385781A (Actelion Epoprostenol) and Flolan® in people with Pulmonary Arterial Hypertension, run by Actelion at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- ACT-385781A (Actelion Epoprostenol) and Flolan®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2010to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado - Denver
Aurora, Colorado, 80045
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
University of California - San Diego
La Jolla, California, 92037
Vanderbilt Medical Center
Nashville, Tennessee, 37232
University of Pennsylvania-Penn Presybyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
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)
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- ACT-385781A (Actelion Epoprostenol), Flolan®
- Keywords
- Pulmonary Arterial Hypertension, PAH, EPITOME-1
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-385781A (Actelion Epoprostenol)Drug
per Prescribing Information
Flolan®Drug
per Prescribing Information
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ACT-385781A (Actelion Epoprostenol) Receives: Drug: ACT-385781A (Actelion Epoprostenol) |
| 2 | Active comparator | Flolan® Receives: Drug: Flolan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wade Benton, PharmD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105117
- Sponsor's protocol ID
- AC-066A402
- Acronym
- EPITOME-1 Ext
- Status last verified
- Nov 2012
- First submitted
- 15 Apr 2010
- Last updated
- 3 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01105117
- Acronym / sponsor ID
- EPITOME-1 Ext / AC-066A402
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension, PAH, EPITOME-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Posted 23 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ACT-385781A (Actelion Epoprostenol)ACT-385781A (Actelion Epoprostenol) |
| 2 | Active comparator | Drug: Flolan®Flolan® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-385781A (Actelion Epoprostenol)per Prescribing Information | Drug | 1 |
| Flolan®per Prescribing Information | Drug | 2 |
Primary outcome
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wade Benton, PharmD study director
Actelion
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACT-385781A (Actelion Epoprostenol) and Flolan® in people with Pulmonary Arterial Hypertension, run by Actelion at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.