Safety and Tolerability of Atomoxetine Hydrochloride in a Long-Term, Placebo-Controlled Randomized Withdrawal Study in European and Non-European Adults with Attention-Deficit/ Hyperactivity Disorder
نویسندگان
چکیده
Background and Objectives: Safety and tolerability of atomoxetine were studied in the largest double-blind, placebo-controlled, randomised withdrawal trial of atomoxetine (80 or 100 mg/day) in adults with attention-deficit/hyperactivity disorder (ADHD). Methods: Patients (N = 2017), 18 to 50 years of age, with ADHD were enrolled from 18 countries. Patients who responded to atomoxetine during a 12-week open-label treatment phase and maintained that response during a 12-week double-blind maintenance phase were randomised to atomoxetine (N = 266) or placebo (N = 258) for 25 weeks of double-blind treatment. Treatment differences were compared for serious adverse events (AEs), treatment-emergent AEs (TEAEs), discontinuation due to AEs, vital signs, body weight, and electrocardiograms. SAFETY OF ATOMOXETINE IN ADULTS WITH ADHD 207
منابع مشابه
Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials.
The safety profile of atomoxetine in the treatment of attention deficit hyperactivity disorder has been studied in many clinical trials. We performed an integrated safety analysis of 15 clinical trials in adults with attention deficit hyperactivity disorder. The analysis pooled patient data into three groups: acute placebo-controlled trials; long-term placebo-controlled trials; all trials. In t...
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