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Shire to compare Vyvanse, Concerta in two Phase IV trials

Tuesday, March 06 2012 | Comments
Evidence Grade 0 What's This?

Shire Plc is commencing two Phase IV clinical studies to compare its Vyvanse (lisdexamfetamine dimesylate) capsules to Janssen Pharmaceuticals Inc.'s Concerta (methylphenidate hydrochloride) extended-release tablets. Both drugs are used to treat attention-deficit/hyperactivity disorder (ADHD). The prospectively designed, randomized, double-blind, head-to-head trials are designed to evaluate differences in efficacy between Vyvanse and Concerta in adolescents aged 13 to 17 years with ADHD....

Shire Plc is commencing two Phase IV clinical studies to compare its Vyvanse (lisdexamfetamine dimesylate) capsules to Janssen Pharmaceuticals Inc.'s Concerta (methylphenidate hydrochloride) extended-release tablets. Both drugs are used to treat attention-deficit/hyperactivity disorder (ADHD).

The prospectively designed, randomized, double-blind, head-to-head trials are designed to evaluate differences in efficacy between Vyvanse and Concerta in adolescents aged 13 to 17 years with ADHD. The total score on the clinician-administered ADHD Rating Scale-IV will be used to compare the efficacy of each treatment.

Trial investigators will follow a dose-optimization design in one study while in the other, a forced-dose titration schedule will be used. In all, approximately 1,000 patients will be involved in the two trials. Results are expected to be available by the second half of next year.

Vyvanse is indicated as a maintenance treatment for adults with ADHD and is approved for the treatment of ADHD in patients aged 6 years or older. Concerta is indicated for the treatment of ADHD in patients aged 6 to 65 years.

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Evidence Grade 0 What's This?

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Evidence Grade 3 What's This?

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Wednesday, October 15 2008 | Comments
Evidence Grade 0 What's This?

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Wednesday, October 15 2008 | Comments
Evidence Grade 7 What's This?

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Tags: ADHD




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