Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Ph 3 Multicenter DBRCT Parallel Group Study to Evaluate Safety & Efficacy of Evening-dosed HLD200, a Novel Delayed & Extended Release Formulation (DELEXIS) of MPH HCl, on Post-waking, Early Morning Function in Children Aged 6-12 With ADHD
Brief Summary: This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of 3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: PRC-063 25 mg and Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: PRC-063 25 mg | Arm Label: PRC-063 45 mg and Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: PRC-063 45 mg | Arm Label: PRC-063 70 mg and Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: PRC-063 70 mg | Arm Label: PRC-063 85 mg and Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: PRC-063 85 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): PRC-063 25 mg and Placebo, PRC-063 45 mg and Placebo, PRC-063 70 mg and Placebo, PRC-063 85 mg and Placebo, Placebo | Intervention Type: DRUG; Name: PRC-063 25 mg; Assigned to Arm(s): PRC-063 25 mg and Placebo | Intervention Type: DRUG; Name: PRC-063 45 mg; Assigned to Arm(s): PRC-063 45 mg and Placebo | Intervention Type: DRUG; Name: PRC-063 70 mg; Assigned to Arm(s): PRC-063 70 mg and Placebo | Intervention Type: DRUG; Name: PRC-063 85 mg; Assigned to Arm(s): PRC-063 85 mg and Placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: Low Dose Methylphenidate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate | Arm Label: Medium Dose Methylphenidate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate | Arm Label: High Dose Methylphenidate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate | Intervention Type: DRUG; Name: Methylphenidate; Assigned to Arm(s): Low Dose Methylphenidate | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Methylphenidate; Assigned to Arm(s): Medium Dose Methylphenidate | Intervention Type: DRUG; Name: Methylphenidate; Assigned to Arm(s): High Dose Methylphenidate
C: Arm Label: HLD200 (methylphenidate); Type: EXPERIMENTAL; Interventions: Drug: HLD200 methylphenidate hydrochloride (MPH) Capsules | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: HLD200 methylphenidate hydrochloride (MPH) Capsules; Assigned to Arm(s): HLD200 (methylphenidate) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Methylphenidate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Methylphenidate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (tablet), Drug: Placebo (capsule) | Arm Label: LY2216684 (0.1 mg/kg/day); Type: EXPERIMENTAL; Interventions: Drug: LY2216684 | Arm Label: LY2216684 (0.2 mg/kg/day); Type: EXPERIMENTAL; Interventions: Drug: LY2216684 | Arm Label: LY2216684 (0.3 mg/kg/day); Type: EXPERIMENTAL; Interventions: Drug: LY2216684 | Intervention Type: DRUG; Name: LY2216684; Assigned to Arm(s): LY2216684 (0.1 mg/kg/day), LY2216684 (0.2 mg/kg/day), LY2216684 (0.3 mg/kg/day) | Intervention Type: DRUG; Name: Methylphenidate; Assigned to Arm(s): Methylphenidate | Intervention Type: DRUG; Name: Placebo (tablet); Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Placebo (capsule); Assigned to Arm(s): Placebo

Answer: C