An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)

• Register: EUCTR
• Last refreshed on: 17 August 2015
• Main ID: EUCTR2010-018320-10-BE
• Date of registration: 13/04/2010
• Prospective Registration: Yes
• Primary sponsor: ACTELION Pharmaceuticals Ltd
• Public title: An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)
• Scientific title: An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension
• Date of first enrolment: 02/07/2010
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018320-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Belgium, Canada, France, Italy, Netherlands, Spain

Contacts

• Name: Global Medical Information
• Affiliation: ACTELION Pharmaceuticals Ltd

• Name: Global Medical Information
• Affiliation: ACTELION Pharmaceuticals Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed informed consent prior to initiation of any study mandated procedure
2. Patients who completed participation in study AC 066A301
3. Patients who have not obtained access (i.e. reimbursement) to commercial EFI at the time of ending participation in study AC-066A301

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion criteria:
1. Patients who prematurely discontinued study drug in study AC-066A301
2. Patients for whom continued treatment with EFI is no longer considered appropriate



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Pulmonary Arterial Hypertension
MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: EPOPROSTENOL SODIUM
CAS Number: 61849-14-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-

Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: EPOPROSTENOL SODIUM
CAS Number: 61849-14-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: - Monthly phone call during the study
- End-of-Study Treatment (EOT) visit
- 24 hours following EOT (phone call)
- 30 days following EOT (phone call)

Primary end point(s): Tolerability / Safety endpoints:
• Treatment-emergent adverse events (AEs) up to 24 hours post-EOT
• Adverse events leading to premature discontinuation of study drug
• Treatment-emergent serious AEs (SAEs) up to 30 days post-EOT

Secondary Objective: NA

Main Objective: To assess safety and tolerability of Epoprostenol for injection in patients with PAH

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: NA

Secondary end point(s): NA

Secondary ID(s)

AC-066A302

Source(s) of Monetary Support

ACTELION Pharmaceuticals Ltd