NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Placebo; Drug: NWP09

Study type: Interventional

Funder types: Industry

Identifiers

NCT01654250

B7491005 (Other Identifier)

NWP09-ADHD-300

Details and patient eligibility

About

The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD

Enrollment: 90 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Exclusion criteria

• Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD

Trial design

90 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

NWP09

Treatment:

Drug: NWP09

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo