Clinical trials recommended or required by the FDA at the time of drug approval<sup>a</sup>.
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aAll information on the trials obtained from ClinicalTrials.gov. bFive trials were conducted by Novartis after the approval of Focalin XR, but all were <1 year in length (longest trial 5 weeks) and none focused on adolescents. cThree phase 4 trials have been registered in ClinicalTrials.gov by Shire since the FDA approval of Vyvanse, including two trials focusing on adolescents. None are listed as completed (NCT01552915, NCT01552902, NCT01328756). dAssuming 135 participants were equally distributed between active and placebo arms.
创建时间:
2014-07-09



