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A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial H...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-000801-50

A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension

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Extrait

To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving endothelin receptor antagonist (ERA), phosphodiesterase (PDE)-5 inhibitor, prostacyclin therapy, or any combination. The change in 6-Minute Walk distance will be evaluated primarily for subjects with access to 0.25 mg tablets at the time of randimization, and secondarily for the overall population.

Critère d'inclusion

  • Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:,1) Appetite suppressant/toxin use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years), or 3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)

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