Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder
Brief Summary: Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characterized by developmentally inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult patients with ADHD is limited, but it is estimated that approximately 50% of children with ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure an effect, which lasts up to 12 hours. Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate. This 5-week period was followed by a 7-week period, where patients received OROS methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete 42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate over a long period of time.

Amendment: At the end of the open-label period of the present study 42603ATT3004, patients are enrolled into a double-blind placebo-controlled period, which lasts an additional 4 weeks. The purpose of this double-blind placebo-controlled period is to evaluate the maintenance of effect under continued treatment with OROS methlyphenidate in comparison to treatment cessation in those patients, who are randomized into the placebo-group.


Options:
A: Arm Label: Methylphenidate; Type: EXPERIMENTAL; Interventions: Drug: Methylphenidate | Arm Label: Matching Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Matching Placebo | Intervention Type: DRUG; Name: Methylphenidate; Assigned to Arm(s): Methylphenidate | Intervention Type: OTHER; Name: Matching Placebo; Assigned to Arm(s): Matching Placebo
B: Arm Label: 001; Type: EXPERIMENTAL; Interventions: Drug: open label PR OROS methylphenidate | Arm Label: 002; Type: EXPERIMENTAL; Interventions: Drug: double blind PR OROS methylphenidate | Arm Label: 003; Type: PLACEBO_COMPARATOR; Interventions: Drug: double blind placebo | Intervention Type: DRUG; Name: double blind placebo; Assigned to Arm(s): 003 | Intervention Type: DRUG; Name: double blind PR OROS methylphenidate; Assigned to Arm(s): 002 | Intervention Type: DRUG; Name: open label PR OROS methylphenidate; Assigned to Arm(s): 001
C: Arm Label: ADHD; Type: N/A; Interventions: N/A
D: Arm Label: Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg; Type: EXPERIMENTAL; Interventions: Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) | Arm Label: Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR); Assigned to Arm(s): Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg, Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B