Trial Outcomes & Findings for Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 (NCT NCT01105117)

NCT ID: NCT01105117

Last Updated: 2012-12-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication
• Results posted on: 2012-12-03

Participant Flow

The study was conducted at Pulmonary Hypertension centers in the U.S.

In this extension study patients could continue on the randomized treatment they received in the core study (AC-066A401) until commercial treatment became available.

Participant milestones

Measure	ACT-385781A (Epoprostenol for Injection) ACT-385781A (Actelion Epoprostenol) ACT-385781A (Actelion Epoprostenol) : per Prescribing Information	Flolan® (Epoprostenol Sodium) for Injection Flolan® Flolan® : per Prescribing Information
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401

Baseline characteristics by cohort

Measure	ACT-385781A (Epoprostenol for Injection) n=1 Participants ACT-385781A (Actelion Epoprostenol) ACT-385781A (Actelion Epoprostenol) : per Prescribing Information	Flolan® (Epoprostenol Sodium) for Injection n=1 Participants Flolan® Flolan® : per Prescribing Information	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 0 • n=5 Participants	34 years STANDARD_DEVIATION 0 • n=7 Participants	44.5 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication

Population: Study population

Outcome measures

Measure	ACT-385781A (Epoprostenol for Injection) n=1 Participants ACT-385781A (Actelion Epoprostenol) ACT-385781A (Actelion Epoprostenol) : per Prescribing Information	Flolan® (Epoprostenol Sodium) for Injection n=1 Participants Flolan® Flolan® : per Prescribing Information
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	0 participants	0 participants

PRIMARY outcome

Timeframe: Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication

Population: Study population

Outcome measures

Measure	ACT-385781A (Epoprostenol for Injection) n=1 Participants ACT-385781A (Actelion Epoprostenol) ACT-385781A (Actelion Epoprostenol) : per Prescribing Information	Flolan® (Epoprostenol Sodium) for Injection n=1 Participants Flolan® Flolan® : per Prescribing Information
Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths	0 participants	0 participants

Adverse Events

ACT-385781A (Epoprostenol for Injection)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Flolan® (Epoprostenol Sodium) for Injection

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	ACT-385781A (Epoprostenol for Injection) n=1 participants at risk ACT-385781A (Actelion Epoprostenol) ACT-385781A (Actelion Epoprostenol) : per Prescribing Information	Flolan® (Epoprostenol Sodium) for Injection n=1 participants at risk Flolan® Flolan® : per Prescribing Information
Cardiac disorders Right ventricular failure	0.00% 0/1 • 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.	100.0% 1/1 • 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.
Gastrointestinal disorders Ascites	0.00% 0/1 • 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.	100.0% 1/1 • 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.

Other adverse events

Measure	ACT-385781A (Epoprostenol for Injection) n=1 participants at risk ACT-385781A (Actelion Epoprostenol) ACT-385781A (Actelion Epoprostenol) : per Prescribing Information	Flolan® (Epoprostenol Sodium) for Injection n=1 participants at risk Flolan® Flolan® : per Prescribing Information
General disorders Catheter site erythema	100.0% 1/1 • 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.	0.00% 0/1 • 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.
Vascular disorders Flushing	0.00% 0/1 • 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.	100.0% 1/1 • 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.

Additional Information

Wade Benton, PharmD, Director of Medical Affairs

Actelion Pharmaceuticals, US

Phone: 650-808-6562

Email: wade.benton@actelion.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place