Trial · NCT01105117
Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
NCT01105117, Phase 4, Completed, Actelion; results first posted 2012-08-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401. Trials, record NCT01105117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01105117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
- NCT number
- NCT01105117
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- ACT-385781A (Actelion Epoprostenol), Flolan®
- First posted
- 2010-04-16
- Last updated
- 2012-12-03
- Results first posted
- 2012-08-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Study population | participants | NUMBER |
| PRIMARY | 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 | Study population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | ACT-385781A (Epoprostenol for Injection) | 0 | participants | ||
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 | Flolan® (Epoprostenol Sodium) for Injection | 0 | participants | ||
| Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths | ACT-385781A (Epoprostenol for Injection) | 0 | participants | ||
| Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths | Flolan® (Epoprostenol Sodium) for Injection | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ACT-385781A (Epoprostenol for Injection) | 1 | |
| Overall Study | STARTED | Flolan® (Epoprostenol Sodium) for Injection | 1 | |
| Overall Study | COMPLETED | ACT-385781A (Epoprostenol for Injection) | 1 | |
| Overall Study | COMPLETED | Flolan® (Epoprostenol Sodium) for Injection | 1 | |
| Overall Study | NOT COMPLETED | ACT-385781A (Epoprostenol for Injection) | 0 | |
| Overall Study | NOT COMPLETED | Flolan® (Epoprostenol Sodium) for Injection | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Catheter site erythema | General disorders | ACT-385781A (Epoprostenol for Injection) | 1 | 1 | |
| other | Catheter site erythema | General disorders | Flolan® (Epoprostenol Sodium) for Injection | 0 | 1 | |
| other | Flushing | Vascular disorders | ACT-385781A (Epoprostenol for Injection) | 0 | 1 | |
| other | Flushing | Vascular disorders | Flolan® (Epoprostenol Sodium) for Injection | 1 | 1 | |
| serious | Right ventricular failure | Cardiac disorders | ACT-385781A (Epoprostenol for Injection) | 0 | 1 | |
| serious | Right ventricular failure | Cardiac disorders | Flolan® (Epoprostenol Sodium) for Injection | 1 | 1 | |
| serious | Ascites | Gastrointestinal disorders | ACT-385781A (Epoprostenol for Injection) | 0 | 1 | |
| serious | Ascites | Gastrointestinal disorders | Flolan® (Epoprostenol Sodium) for Injection | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ACT-385781A (Epoprostenol for Injection) | ||
| Total, all-cause mortality | Flolan® (Epoprostenol Sodium) for Injection | ||
| Total, other adverse events | ACT-385781A (Epoprostenol for Injection) | 1 | 1 |
| Total, other adverse events | Flolan® (Epoprostenol Sodium) for Injection | 1 | 1 |
| Total, serious adverse events | ACT-385781A (Epoprostenol for Injection) | 0 | 1 |
| Total, serious adverse events | Flolan® (Epoprostenol Sodium) for Injection | 1 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
ACT-385781A (Epoprostenol for Injection) vs Flolan® (Epoprostenol Sodium) for Injection: Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths | Trial comparisons |
ACT-385781A (Epoprostenol for Injection) vs Flolan® (Epoprostenol Sodium) for Injection: 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 | Trial comparisons |
| ACT-385781A (Epoprostenol for Injection) vs Flolan® (Epoprostenol Sodium) for Injection: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01105117
GET https://conductscience.org/api/trials/v1/NCT01105117/registered