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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | ACT-385781A (Actelion Epoprostenol) |
|
| 2 | Active Comparator | Flolan® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-385781A (Actelion Epoprostenol) | Drug | per Prescribing Information |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wade Benton, PharmD | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Diego | La Jolla | California | 92037 | United States | ||
| University of Colorado - Denver |
In this extension study patients could continue on the randomized treatment they received in the core study (AC-066A401) until commercial treatment became available.
The study was conducted at Pulmonary Hypertension centers in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACT-385781A (Epoprostenol for Injection) | ACT-385781A (Actelion Epoprostenol) ACT-385781A (Actelion Epoprostenol) : per Prescribing Information |
| FG001 | Flolan® (Epoprostenol Sodium) for Injection | Flolan® Flolan® : per Prescribing Information |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACT-385781A (Epoprostenol for Injection) | ACT-385781A (Actelion Epoprostenol) ACT-385781A (Actelion Epoprostenol) : per Prescribing Information |
| BG001 | Flolan® (Epoprostenol Sodium) for Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Study population | Posted | Number | participants | Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication |
|
Screening to day 28 for treatment-emergent (TE) adverse events (AEs) up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
Assessment of safety was based on the collection of AEs, including SAEs and AEs that resulted in discontinuation of study treatment. All AEs that occurred up to the end of the last day of study treatment were recorded in the CRF and included in the clinical database. SAEs and deaths that occurred up to 30 days after the end of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACT-385781A (Epoprostenol for Injection) | ACT-385781A (Actelion Epoprostenol) ACT-385781A (Actelion Epoprostenol) : per Prescribing Information |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right ventricular failure | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site erythema | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wade Benton, PharmD, Director of Medical Affairs | Actelion Pharmaceuticals, US | 650-808-6562 | wade.benton@actelion.com |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011464 | Epoprostenol |
| ID | Term |
|---|---|
| D044062 | Prostaglandins I |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Flolan® |
| Drug |
per Prescribing Information |
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Pennsylvania-Penn Presybyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
Flolan®
Flolan® : per Prescribing Information
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths | Study population | Posted | Number | participants | Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication |
|
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Flolan® (Epoprostenol Sodium) for Injection | Flolan® Flolan® : per Prescribing Information | 1 | 1 | 1 | 1 |
| Ascites | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |