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A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00880217 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2013-03-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety/tolerability of 3 different dosages of JNJ-31001074 compared with placebo in adult patients with attention-deficit/hyperactivity disorder (ADHD).

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Atomoxetine 80 mg/d

40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days

DRUG

Placebo

Placebo capsule once daily for 42 days

DRUG

OROS methylphenidate HCl 54 mg/d

36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days

DRUG

JNJ-31001074 3 mg/d

3-mg capsule once daily for 42 days

DRUG

JNJ-31001074 1 mg/d

1-mg capsule once daily for 42 days

DRUG

JNJ-31001074 10 mg/d

10-mg capsule once daily for 42 days

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT00880217 on ClinicalTrials.gov