An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension

Update Il y a 4 ans
Reference: EUCTR2005-002844-24

Woman and Man

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Extract

This study has 2 parts: (a) a blinded 52 week phase (Part 1), and (b) an open label phase (Part 2). The primary objective of Part 1 is to evaluate the long term safety of tadalafil 20 mg and 40 mg once daily in the treatment of patients with PAH. The primary objective of Part 2 is to evaluate long term safety while providing continued access to tadalafil for patients completing Part 1.


Inclusion criteria

  • Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death