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A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder

NCT00714688 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2014-05-08

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).

Conditions

  • Attention Deficit/ Hyperactivity Disorder

Interventions

DRUG

prolonged release (PR) OROS methylphenidate 54 mg

18+36mg once daily for 13 weeks

DRUG

prolonged release (PR) OROS methylphenidate 72 mg

2x36mg once daily for 13 weeks

DRUG

Placebo

2xplacebo once daily for 13 weeks

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT00714688 on ClinicalTrials.gov