Conditions: Attention Deficit Hyperactivity Disorder ADHD
Keywords: inattention impulsivity hyperactivity ADHD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 230
Healthy volunteers: no

Brief summary:
This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.

Detailed description:
This is a parallel, randomized, double-blind, multi-center, placebo-controlled, forced dose, phase 3 study to evaluate the safety and efficacy of Biphentin® methylphenidate hydrochloride (HCl) extended release (ER) capsules in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years.

The primary objective was to assess the efficacy of Biphentin compared to placebo, in the clinic setting, as measured by the clinician-administered parent version of the ADHD-RS-IV.

Subjects who met study entry criteria were enrolled in the Double-blind Phase and were randomized to either a fixed dose of Biphentin (!0, 15, 20, or 40 mg/day) or placebo capsule taken daily in the morning for 1 week. Subjects then continued into an Open-label Phase that included dose optimization with doses starting at 10 mg and allowed up to 60 mg. The open-label period following the one double-blind fixed dose week provides additional opportunity for subjects to receive treatment with Biphentin. Extra unscheduled dose optimization visits are allowed as needed for additional dose titration visits during the open-label period.

The safety and tolerability, and efficacy assessments will be conducted throughout the study.

Biphentin® is designed to be a single daily dose alternative to separate doses of immediate release methylphenidate by providing a biphasic plasma profile. It achieves a first Cmax more similar to immediate release methylphenidate.

Arms:
arm 1: Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg arm 2: Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg arm 3: Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg arm 4: Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg arm 5: Placebo capsules arm 6: Biphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 40, 50 or 60 mg) - Open Label Phase

Interventions: intervention 1: Methylphenidate Hydrochloride Extended Release Capsules intervention 2: Placebo
Intervention descriptions: intervention 1: Biphentin Methylphenidate ER Once-A-Day Capsules intervention 2: Placebo capsules

Protocol document: