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Veletri vs Flolan in PAH
NCT01105091Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2010
- Primary completion
- May 2011
- Sponsor
- Actelion Pharmaceuticals Ltd
- Modality
- Orthosteric Ligands
- Drugs
- epoprostenol
- Conditions
- pulmonary arterial hypertension (PAH)
01
Overview
Phase 4, randomised, open-label trial of epoprostenol in pulmonary arterial hypertension (PAH) (2 arms), sponsored by Actelion Pharmaceuticals Ltd. Primary endpoints: Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at Day 1, Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at Day 1 and 6 more. Started Mar 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Veletri
ACT-385781A (Actelion Epoprostenol)
Flolan
Epoprostenol sodium (Flolan)
03
Who it enrols
Patients aged 18-65 with WHO Group I PAH (Idiopathic, Heritable, or Associated) in NYHA Class III or IV, naïve to injectable prostanoid treatment. Patients may be newly diagnosed or on stable background therapy (Bosentan, Ambrisentan, Sildenafil, Tadalafil).
04
Endpoints
Primary
Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha
Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha
Six-minute Walk Distance
New York Heart Association Functional Class Change
Central Venous Blood Oxygen Saturation
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