Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension (EPITOME-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01431716
First received: September 7, 2011
Last updated: January 2, 2015
Last verified: January 2015

September 7, 2011
January 2, 2015
March 2011
February 2012   (final data collection date for primary outcome measure)
  • Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT). [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
  • Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT). [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
  • Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT). [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
  • Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT). [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
  • Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT). [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
  • Change in Mean Cardiac Index From Baseline to End of Treatment (EOT). [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Change in cardiac hemodynamics [ Time Frame: Baseline to end of study (3 months) ] [ Designated as safety issue: No ]
Change in cardiac hemodynamics from baseline to end of study (3-months) following switch from Flolan to Epoprostenol
Complete list of historical versions of study NCT01431716 on ClinicalTrials.gov Archive Site
Not Provided
Change in 6-minute walk distance (6MWD) [ Time Frame: Baseline to end of study (3 months) ] [ Designated as safety issue: No ]
Change from basline to end of study (3 months)in 6-minute walk distance (6MWD)
  • Change in 6-minute Walk Distance (6MWD) From Baseline to EOT. [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    The 6MWD was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The 6-minute walk test is a non-encouraged test that measures the distance walked for the duration of 6 min.
  • Change in Borg Dyspnea Score From Baseline to EOT. [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    The Borg dyspnea score was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labelled "extremely severe," or "the worst possible dyspnea imaginable."
  • Number of Participants With Improved, No Change, or Worsening of New York Heart Association Functional Class (NYHA FC) From Baseline to EOT. [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    NYHA FC was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. Disease severity was assessed by NYHA classification of pulmonary arterial hypertension criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
  • Change in N-terminal Pro-B-type Natriuretic Peptide (NT proBNP) From Baseline to EOT. [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Blood sampling for NT proBNP was performed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
  • Change in Effectiveness Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT. [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question effectiveness scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
  • Change in Convenience Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT. [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question convenience scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
  • Change in Global Satisfaction Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT. [ Time Frame: Approximately 3 months ] [ Designated as safety issue: No ]
    Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question global satisfaction scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.
  • Number of Participants With Adverse Events Leading to Discontinuation of Study Drug From Baseline to EOT. [ Time Frame: Approximately 3 months ] [ Designated as safety issue: Yes ]
    Adverse events that led to discontinuation of study drug from the start of study treatment until the end of study treatment were recorded.
Not Provided
 
Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: EFI/ACT-385781A
Other Names:
  • ACT-385781A
  • Epoprostenol for injection (EFI)
Experimental: EFI/ACT-385781A
EFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump
Intervention: Drug: EFI/ACT-385781A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Italy,   Netherlands,   Spain
 
NCT01431716
AC-066A301
No
Actelion
Actelion
Not Provided
Not Provided
Actelion
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP