NCT01431716: EPITOME-2

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

Completed Phase 3 Results posted Last updated 2 January 2015

What this trial tests

Phase 3 trial testing EFI/ACT-385781A in Pulmonary Arterial Hypertension in 42 participants. Completed in 1 July 2012.

Timeline

1 March 2011

Primary endpoint
1 February 2012

1 July 2012

Quick facts

Lead sponsor	Actelion
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	1 March 2011
Primary completion	1 February 2012
Estimated completion	1 July 2012
Sites	8 locations across Belgium, Canada, France, Italy, Netherlands, Spain

Drugs / interventions tested

• EFI/ACT-385781A — full drug profile →

Conditions studied

• Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →

Sponsor

Actelion — full company profile →

Who can join

18 and older, any sex, with Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.