Trial · NCT01105091
Epoprostenol for Injection in Pulmonary Arterial Hypertension
NCT01105091, Phase 4, Completed, Actelion; results first posted 2012-08-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Epoprostenol for Injection in Pulmonary Arterial Hypertension. Trials, record NCT01105091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01105091
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
- NCT number
- NCT01105091
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 30 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- ACT-385781A (Actelion Epoprostenol), Flolan®
- First posted
- 2010-04-16
- Last updated
- 2025-02-04
- Results first posted
- 2012-08-23
- Limitations and caveats
- The EPITOME-1 study is an open label study without a primary endpoint. The sample size was determined based on feasibility and not a power calculation.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min | Day 1 | The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results. |
| Primary | Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min | Day 1 | The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results. |
| Primary | Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min | Day 1 | The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results. |
| Primary | Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min | Day 1 | The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results. |
| Primary | Six-minute Walk Distance (6MWD) - Baseline and Day 28 | Baseline and 28 days (+3 days) | The 6-minute walk test (6MWT) was to be performed prior to initiating study treatment either during the screening visit or on Day 1 prior to drug initiation, and Day 28 (End of treatment (EOT)). This assessment is a non-encouraged test that measures the distance walked for a duration of 6 minutes. The 6MWD was recorded in the Case Report Form (CRF). |
| Primary | Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28 | From baseline to 28 days (+3 days) | Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA. |
| Primary | Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28 | Baseline and 28 days | Central venous blood oxygen saturation assessment was performed only in specific centers. Measurements for ScVO2 were performed during the inpatient hospitalization period on Day 1 (prior to drug initiation) and on Day 28 (EOT). Samples for ScVO2 were obtained by aspirating blood from the indwelling central venous catheter. After the sample had been drawn, the catheter was primed with study drug in order to refill the lumen to avoid interruption in treatment and sudden decompensation. |
| Primary | Blood Pressure - Baseline and Day 28 | Baseline and 28 days | Blood pressure (systolic and diastolic) were measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Blood Pressure was assessed at baseline and at Day 28 (End of Study Treatment visit). |
| Primary | Heart Rate - Baseline and Day 28 | Baseline and 28 days | Heart rate was measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Heart Rate was assessed at Baseline and at Day 28 (End of Study Treatment visit). |
| Primary | Body Weight - Baseline and Day 28 | Baseline and 28 days | Body weight was measured both at baseline and day 28. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min | Day 1 | A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints. | (pg/ml)/(ng/kg/min) | MEDIAN |
| PRIMARY | Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min | Day 1 | A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints. | (pg/ml)/(ng/kg/min) | MEDIAN |
| PRIMARY | Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min | Day 1 | A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints. | (pg/ml)/(ng/kg/min) | MEDIAN |
| PRIMARY | Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min | Day 1 | A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints. | (pg/ml)/(ng/kg/min) | MEDIAN |
| PRIMARY | Six-minute Walk Distance (6MWD) - Baseline and Day 28 | Baseline and 28 days (+3 days) | Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values. | meters | MEDIAN |
| PRIMARY | Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28 | From baseline to 28 days (+3 days) | Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values. | participants | NUMBER |
| PRIMARY | Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28 | Baseline and 28 days | Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values. | percentage oxygen saturation | MEDIAN |
| PRIMARY | Blood Pressure - Baseline and Day 28 | Baseline and 28 days | Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values. | mm Hg | MEDIAN |
| PRIMARY | Heart Rate - Baseline and Day 28 | Baseline and 28 days | Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values. | Beats per minute | MEDIAN |
| PRIMARY | Body Weight - Baseline and Day 28 | Baseline and 28 days | Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values. | kg | MEDIAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min | ACT-385781A (Epoprostenol for Injection) | 98.0 | Full Range 12.5 to 416.5 | (pg/ml)/(ng/kg/min) | |
| Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min | Flolan® (Epoprostenol Sodium) for Injection | 83.1 | Full Range 36.0 to 158.5 | (pg/ml)/(ng/kg/min) | |
| Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min | ACT-385781A (Epoprostenol for Injection) | 90.9 | Full Range 29.3 to 195.0 | (pg/ml)/(ng/kg/min) | |
| Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min | Flolan® (Epoprostenol Sodium) for Injection | 59.6 | Full Range 24.9 to 170.5 | (pg/ml)/(ng/kg/min) | |
| Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min | ACT-385781A (Epoprostenol for Injection) | 85.5 | Full Range 12.5 to 374.5 | (pg/ml)/(ng/kg/min) | |
| Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min | Flolan® (Epoprostenol Sodium) for Injection | 109.2 | Full Range 38.4 to 152.0 | (pg/ml)/(ng/kg/min) | |
| Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min | ACT-385781A (Epoprostenol for Injection) | 93.1 | Full Range 29.8 to 457.5 | (pg/ml)/(ng/kg/min) | |
| Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min | Flolan® (Epoprostenol Sodium) for Injection | 95.0 | Full Range 33.3 to 201.0 | (pg/ml)/(ng/kg/min) | |
| Six-minute Walk Distance (6MWD) - Baseline and Day 28 | ACT-385781A (Epoprostenol for Injection) | Baseline | 339.0 | Full Range 84 | meters |
| Six-minute Walk Distance (6MWD) - Baseline and Day 28 | Flolan (Epoprostenol Sodium) for Injection | Baseline | 302.5 | Full Range 58.8 | meters |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant 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) | 20 | |
| Overall Study | STARTED | Flolan® (Epoprostenol Sodium) for Injection | 10 | |
| Overall Study | COMPLETED | ACT-385781A (Epoprostenol for Injection) | 18 | |
| Overall Study | COMPLETED | Flolan® (Epoprostenol Sodium) for Injection | 10 | |
| Overall Study | NOT COMPLETED | ACT-385781A (Epoprostenol for Injection) | 2 | |
| Overall Study | NOT COMPLETED | Flolan® (Epoprostenol Sodium) for Injection | 0 |
Source ClinicalTrials.gov
Adverse events186
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 | Abdominal Distension | Gastrointestinal disorders | ACT-385781A (Epoprostenol for Injection) | 1 | 20 | 1 |
| other | Abdominal Distension | Gastrointestinal disorders | Flolan® (Epoprostenol Sodium) for Injection | 0 | 10 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | ACT-385781A (Epoprostenol for Injection) | 1 | 20 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Flolan® (Epoprostenol Sodium) for Injection | 0 | 10 | 0 |
| other | Adverse Drug Reaction | General disorders | ACT-385781A (Epoprostenol for Injection) | 1 | 20 | 1 |
| other | Adverse Drug Reaction | General disorders | Flolan® (Epoprostenol Sodium) for Injection | 0 | 10 | 0 |
| other | Anemia | Blood and lymphatic system disorders | ACT-385781A (Epoprostenol for Injection) | 1 | 20 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Flolan® (Epoprostenol Sodium) for Injection | 1 | 10 | 1 |
| other | Anxiety | Psychiatric disorders | ACT-385781A (Epoprostenol for Injection) | 1 | 20 | 1 |
| other | Anxiety | Psychiatric disorders | Flolan® (Epoprostenol Sodium) for Injection | 0 | 10 | 0 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse 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) | 20 | 20 |
| Total, other adverse events | Flolan® (Epoprostenol Sodium) for Injection | 10 | 10 |
| Total, serious adverse events | ACT-385781A (Epoprostenol for Injection) | 6 | 20 |
| Total, serious adverse events | Flolan® (Epoprostenol Sodium) for Injection | 2 | 10 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ACT-385781A (Epoprostenol for Injection) vs Flolan® (Epoprostenol Sodium) for Injection: serious adverse events |
Source 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/NCT01105091
GET https://conductscience.org/api/trials/v1/NCT01105091/results?page=2