Woman and Man
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Extract
Period 1 primary objectives: For the EU regulatory assessment, the primary objective of Period 1 is to evaluate the efficacy of tadalafil compared with placebo, as measured by time to clinical worsening (CW) in pediatric PAH patients through Week 24. For the United States (US) regulatory assessment, the primary objective of Period 1 is to evaluate the efficacy of tadalafil compared with placebo in improving 6-minute walk distance from bBaseline to Week-24 as assessed in a subset of patients ≥6 to <18 years of age who are developmentally capable of performing a 6MW test. Period 2 Primary Objective: The primary objective of Period 2 is to evaluate long-term safety of tadalafil while providing continued access to tadalafil for pediatric patients with PAH who participated in Period 1
Inclusion criteria
- pulmonary arterial hypertension