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ADDERALL-XR (AMPHETAMINE, DEXTROAMPHETAMINE): CLINICAL STUDIES

Pediatric Patients

A double-blind, randomized, placebo-controlled, parallel-group study was conducted in children aged 612 (N=584) who met DSM-IVR criteria for ADHD (either the combined type or the hyperactiveimpulsive type). Patients were randomized to fixed-dose treatment groups receiving final doses of 10, 20, or 30 mg of Adderall-XR (Amphetamines with Dextroamphetamines) or placebo once daily in the morning for three weeks. Significant improvements in patient behavior, based upon teacher ratings of attention and hyperactivity, were observed for all Adderall-XR doses compared to patients who received placebo, for all three weeks, including the first week of treatment, when all Amphetamine with Dextroamphetamine (Adderall-XR) subjects were receiving a dose of 10 mg/day. Patients who received this medicine showed behavioral improvements in both morning and afternoon assessments compared to patients on placebo.

In a classroom analogue study, patients (N=51) receiving fixed doses of 10 mg, 20 mg or 30 mg Amphetamines and Dextroamphetamines (Adderall-XR) demonstrated statistically significant improvements in teacher-rated behavior and performance measures, compared to patients treated with placebo.

A double-blind, randomized, multi-center, parallel-group, placebo-controlled study was conducted in adolescents aged 13-17 (N=327) who met DSM-IVR criteria for ADHD. The primary cohort of patients (n=287, weighing <= 75kg/165lbs) was randomized to fixed-dose treatment groups and received four weeks of treatment. Patients were randomized to receive final doses of 10 mg, 20 mg, 30 mg, and 40 mg mixed salts of Amphetamine and Dextroamphetamine (Adderall-XR) or placebo once daily in the morning. Patients randomized to doses greater than 10 mg were titrated to their final doses by 10 mg each week. The secondary cohort consisted of 40 subjects weighing > 75kg/165lbs who were randomized to fixed-dose treatment groups receiving final doses of 50 mg and 60 mg Adderall-XR (Amphetamine, Dextroamphetamine) capsules or placebo once daily in the morning for 4 weeks. The primary efficacy variable was the Attention Deficit Hyperactivity Disorder-Rating Scale IV (ADHD-RS-IV) total score for the primary cohort. The ADHD-RS-IV is an 18-item scale that measures the core symptoms of ADHD. Improvements in the primary cohort were statistically significantly greater in all four primary cohort active treatment groups (Adderall-XR 10 mg, 20 mg, 30 mg, and 40 mg) compared with the placebo group. There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit.

Adult Patients

A double-blind, randomized, placebo-controlled, parallel-group study was conducted in adults (N=255) who met DSM-IVR criteria for ADHD. Patients were randomized to fixed-dose treatment groups receiving final doses of 20, 40, or 60 mg of Adderall-XR (Amphetamine, Dextroamphetamine) or placebo once daily in the morning for four weeks. Significant improvements, measured with the Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS), an 18- item scale that measures the core symptoms of ADHD, were observed at endpoint for all Adderall-XR (Amphetamine, Dextroamphetamine mixed salts) doses compared to patients who received placebo for all four weeks.

There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit.



Adderall-XR related pharmaceutical drugs and medications

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Methylphenidate Pro Doc - Methylphenidate Hydrochloride
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