Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01431716
• Date of registration: 07/09/2011
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension EPITOME-2
• Scientific title: A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial Hypertension
• Date of first enrolment: March 2011
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01431716
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, France, Italy, Netherlands, Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female aged 18 years and above

2. Patients with the following types of pulmonary arterial hypertension (PAH) belonging
to WHO Group I: Idiopathic (IPAH), Heritable (HPAH), Associated (APAH) with Connective
tissue diseases or Drugs and toxins

3. Patients treated with Flolan® for at least 12 months and on a stable dose for at least
3 months prior to enrollment

4. Patients who are currently treated with concomitant PAH therapy listed below must have
been treated for at least 90 days and on a stable dose for 30 days prior to
enrollment: Bosentan, Ambrisentan, Sitaxsentan, Sildenafil, Tadalafil

5. Women of childbearing potential must use a reliable method of contraception

6. Signed informed consent prior to initiation of any study mandated procedure

Exclusion Criteria:

1. Patients with respiratory and/or cardiovascular distress in need of emergency care

2. Known or suspicion of pulmonary veno-occlusive disease (PVOD)

3. Current use of IV inotropic agents

4. Current use of any prostacyclin or prostacyclin analog other than Flolan®

5. Tachycardia with heart rate > 120 beats/min at rest

6. PAH related to any condition other than those specified in the inclusion criteria

7. Known hypersensitivity to the formulations EFI/ACT-385781A or any of its excipients,
and Flolan® or any of its excipients

8. Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of
screening

9. History of myocardial infarction

10. History of left-sided heart disease, including any of the following:

- hemodynamically significant aortic or mitral valve disease

- restrictive or congestive cardiomyopathy

- left ventricular ejection fraction < 40% by multigated radionucleotide angiogram
(MUGA), angiography, or echocardiography

- unstable angina pectoris

- life-threatening cardiac arrhythmias

11. Chronic bleeding disorders

12. Central venous line infection within 90 days prior to screening and/or a history of
recurring line infections

13. Women who are pregnant or breast-feeding

14. Participation in another clinical trial, except observational, or receipt of an
investigational product within 30 days prior to randomization

15. Any known factor or disease that might interfere with treatment compliance, study
conduct or interpretation of the results such as drug or alcohol dependence or
psychiatric disease

16. Known concomitant life-threatening disease other than PAH with a life expectancy < 12
months



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: EFI/ACT-385781A

Primary Outcome(s)

Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT). [Time Frame: Approximately 3 months]

Change in Mean Cardiac Index From Baseline to End of Treatment (EOT). [Time Frame: Approximately 3 months]

Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT). [Time Frame: Approximately 3 months]

Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT). [Time Frame: Approximately 3 months]

Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT). [Time Frame: Approximately 3 months]

Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT). [Time Frame: Approximately 3 months]

Secondary ID(s)

AC-066A301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/01/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01431716