Phase 3
Completed N=42
Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT01431716 ↗Enrolled (actual)
42
Serious AEs
17.1%
Results posted
Jan 2015
Primary outcomePrimary: Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT). — 595.70; 587.66 dyn/sec/cm^5
Summary
This study is investigating the effect of switching from Flolan® to Epoprostenol for Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated with Flolan®. For this purpose patients being treated for at least 12 months with Flolan® will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety, tolerability, efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients with pulmonary arterial hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT). |
595.70; 587.66 | — |
| PRIMARY Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT). |
752.44; 757.51 | — |
| PRIMARY Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT). |
51.9; 51.7 | — |
| PRIMARY Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT). |
7.9; 7.1 | — |
| PRIMARY Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT). |
10.3; 10.1 | — |
| PRIMARY Change in Mean Cardiac Index From Baseline to End of Treatment (EOT). |
3.34; 3.38 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female aged 18 years and above
- 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
- Patients treated with Flolan® for at least 12 months and on a stable dose for at least 3 months prior to enrollment
- 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
- Women of childbearing potential must use a reliable method of contraception
- Signed informed consent prior to initiation of any study mandated procedure
Exclusion Criteria
- Patients with respiratory and/or cardiovascular distress in need of emergency care
- Known or suspicion of pulmonary veno-occlusive disease (PVOD)
- Current use of IV inotropic agents
- Current use of any prostacyclin or prostacyclin analog other than Flolan®
- Tachycardia with heart rate > 120 beats/min at rest
- PAH related to any condition other than those specified in the inclusion criteria
- Known hypersensitivity to the formulations EFI/ACT-385781A or any of its excipients, and Flolan® or any of its excipients
- Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
- History of myocardial infarction
- 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
- Chronic bleeding disorders
- Central venous line infection within 90 days prior to screening and/or a history of recurring line infections
- Women who are pregnant or breast-feeding
- Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to randomization
- 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
- Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months
Data sourced from ClinicalTrials.gov (NCT01431716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.