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NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD

NCT00557011 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2011-05-25

No results posted yet for this study

Summary

The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

NRP104

30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning

DRUG

Adderall XR

10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg

DRUG

Placebo

Placebo capsule taken once daily in the morning

Sponsors & Collaborators

  • New River Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joseph Biederman, M.D. · Harvard Medical School (HMS and HSDM)

  • Samuel Boellner, M.D. · Clinical Study Centers, LLC

  • Ann Childress, M.D. · Center for Psychiatry And Behavioral Medicine Inc.

  • Frank Lopez, M.D.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2004-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557011 on ClinicalTrials.gov