A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2
- Conditions
- Pulmonary Arterial HypertensionMedDRA version: 12.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
- Registration Number
- EUCTR2010-018322-40-NL
- Lead Sponsor
- ACTELION Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 35
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
o Connective tissue diseases
o 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
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 of EFI 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 enrollment
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the change in cardiac hemodynamics from baseline to 3-month following switch from Flolan® to EFI in patients with pulmonary arterial hypertension (PAH).<br>• To evaluate the safety and tolerability of switching from Flolan® to EFI in patients with PAH.<br><br>;Secondary Objective: Not Applicable;Primary end point(s): Tolerability / Safety endpoints:<br>• Treatment-emergent adverse events (AEs) up to 24 hours post-EOT<br>• Change from baseline to EOT in vital signs [heart rate (HR) and blood pressure (BP)] and body weight<br>• AEs leading to premature discontinuation of study drug <br>• Treatment-emergent serious AEs (SAEs) up to 30 days post-EOT<br><br><br>Efficacy endpoint:<br>• Change from baseline to EOT in cardiac hemodynamics including:<br>o Pulmonary vascular resistance (PVR)<br>o Mean pulmonary arterial pressure (mPAP)<br>o Right atrial pressure (RAP)<br>o Pulmonary artery occlusion pressure (PAOP)<br>o Cardiac index (CI)<br><br><br>
- Secondary Outcome Measures
Name Time Method