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Clinical Trials

  1. The subjects in the trial were adolescents aged 13 to 17 years with ADHD. The majority of the subjects were male (65.5%) and white (73.7%). Most of the subjects had AHDH combined inattentive/hyperactive-impulsive subtype (56.6%). In addition, 78.8% of subjects were treatment naïve while 21.2% had received treatment of ADHD within 30 days before their screening.
  2. The intervention consisted of the efficacy and safety of MAS XR in the management of adolescents with ADHD were examined in this 4-week, randomized, multicenter, double-blind, placebo-controlled, parallel-group, forced-dose-titration study. In the clinical trial the medication MAS XR was given among the subjects which were randomized to 1 of 4 active treatments (MAS XR 10, 20, 30, or 40 rag/d) or to placebo. According to the study, the intervention consisted of a forced-dose-titration design in which patients randomized to the 10-mg/d group received 1 dose of 10 mg/d for 4 weeks. Patients randomized to the 20-mg/d group received 1 dose of 10 mg/d for the first week and 1 dose of 20 mg/d for the remaining weeks; patients randomized to the 30-mg/d group received 1 dose of 10 mg/d for the first week, 1 dose of 20 mg/d for the second week, and 1 dose of 30 mg/d for the remaining 2 weeks; and patients randomized to the 40-mg/d group received 1 dose of 10 mg/d for the first week, 1 dose of 20 mg/d for the second week, 1 dose of 30 mg/d for the third week, and 1 dose of 40 mg/d for the fourth week.
  3. Some of the outcomes that were observed were: adverse events (AE), vital signs, and body weight at each study visit and 30 days after drug discontinuation. All of the previous components of observation in the study can be classified as being related to drug safety. In addition to the previous outcomes observed, two outcomes that can be seen as related to drug efficacy within the trial were: A) The primary efficacy measure was changed from baseline to endpoint in the ADHD Rating Scale-IV (ADHD-RS-IV) score. B) The secondary efficacy measure was the score on the Clinical Global Impressions-Improvement (CGI-I) scale for ADHD.
  4. What can be concluded from this trial is that the results of this placebo-controlled, forced-dose-titration study indicated that statistically significant improvements in core ADHD symptoms occurred in these adolescents with ADHD who received HAS XR compared with placebo, 63.3% of adolescents receiving active treatment with HAS XR were considered to be “much improved” or “very much improved.”  However, one dose daily of 40 mg MAS XR was concluded to be the most effective and well tolerated for the management of ADHD in adolescents. In addition, the most reported adverse events were mild and moderate, and changes in vital signs were not clinically significant.

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