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Completed

NCT Number: NCT01431716

Epoprostenol for Injection (EFI/ACT-385781A) - 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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZ Gasthuisberg, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EFI/ACT-385781A

Drug

Other names: ACT-385781A, Epoprostenol for injection (EFI)

Primary outcomes

  1. Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).

    Time frame: Approximately 3 months

    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.

  2. Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).

    Time frame: Approximately 3 months

    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.

  3. Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).

    Time frame: Approximately 3 months

    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.

  4. Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).

    Time frame: Approximately 3 months

    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.

  5. Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).

    Time frame: Approximately 3 months

    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.

  6. Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).

    Time frame: Approximately 3 months

    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.

Other outcomes

  1. Change in 6-minute Walk Distance (6MWD) From Baseline to EOT.

    Time frame: Approximately 3 months

    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.

  2. Change in Borg Dyspnea Score From Baseline to EOT.

    Time frame: Approximately 3 months

    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."

  3. 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

    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.

  4. Change in N-terminal Pro-B-type Natriuretic Peptide (NT proBNP) From Baseline to EOT.

    Time frame: Approximately 3 months

    Blood sampling for NT proBNP was performed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

  5. Change in Effectiveness Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.

    Time frame: Approximately 3 months

    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.

  6. Change in Convenience Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.

    Time frame: Approximately 3 months

    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.

  7. Change in Global Satisfaction Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.

    Time frame: Approximately 3 months

    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.

  8. Number of Participants With Adverse Events Leading to Discontinuation of Study Drug From Baseline to EOT.

    Time frame: Approximately 3 months

    Adverse events that led to discontinuation of study drug from the start of study treatment until the end of study treatment were recorded.

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study 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

Acronym: EPITOME-2

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 12, 2011
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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