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Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD

NCT01239030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2023-02-22

Study results available
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Summary

This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.

Conditions

  • Attention Deficit Hyperactivity Disorder
  • ADHD

Interventions

DRUG

Methylphenidate Hydrochloride Extended Release Capsules

Biphentin Methylphenidate ER Once-A-Day Capsules

DRUG

Placebo

Placebo capsules

Sponsors & Collaborators

  • Rhodes Pharmaceuticals, L.P.

    lead INDUSTRY

Principal Investigators

  • Wei-wei Chang, Ph.D. · NuTec Incorporated

  • Laurence Greenhill, M.D. · New York State Psychiatric Institute / Columbia University

  • Sharon B. Wigal, Ph.D. · University of California, Irvine / Child Development Center

  • Robert J. Kupper, Ph.D. · Rhodes Phamaceuticals, L.P.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01239030 on ClinicalTrials.gov