Shionogi Inc. announced that data from its Phase 3 study of Kapvay (clonidine hydrochloride) extended-release tablets combined with stimulant medications for the treatment of attention deficit hyperactivity disorder in children and adolescents 6–17 years of age. This eight-week, randomized, double-blind, placebo-controlled trial of 198 children and adolescents with ADHD compared patients treated with Kapvay + stimulant (n=102) to a placebo + stimulant (n=96). Signs and symptoms of ADHD were evaluated using the investigator administered and scored ADHD Rating Scale-IV-Parent Version (ADHD-RS-IV) total score.
Patients in the Kapvay group demonstrated significant efficacy at Week 5, meeting the primary endpoint. At Week 5, greater improvement from baseline was observed in the Kapvay group compared with the placebo group in the following scales: ADHD-RS-IV total score (95% CI, -7.83 to -1.13; P=0.009) as well as the ADHD-RS-IV hyperactivity/impulsivity and inattention subscale scores (P=0.014 and P=0.017, respectively). In addition, the study also showed that improvement in the ADHDRS-IV total score from baseline was statistically significant between the Kapvay group and the placebo group beginning at Week 2 and was maintained during the trial
Kapvay is a centrally acting alpha2-adrenoceptor agonist. The formulation of Kapvay is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences. Kapvay is indicated for the treatment of ADHD as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents.
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