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Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD

NCT00556296 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2011-06-21

No results posted yet for this study

Summary

This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

NRP104

NRP104 30mg capsule once daily in a.m.

DRUG

NRP104

NRP104 50mg capsule once daily in a.m.

DRUG

NRp104

NRP104 70mg capsule once daily in a.m.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • New River Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suma Krishnan · New River Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-10-31
Completion
2005-09-30

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Entities

Drugs

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 NCT00556296 on ClinicalTrials.gov