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NCT00334880 · ClinicalTrials.gov registry record · Phase 3

Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

A Phase 3 study of Attention Deficit Hyperactivity Disorder and Attention Deficit Disorders With Hyperactivity, sponsored by New River Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
420
Enrollment target
20
Study locations

NCT00334880 is a Phase 3 study of Attention Deficit Hyperactivity Disorder and Attention Deficit Disorders With Hyperactivity that has completed, run by New River Pharmaceuticals. The registered enrollment target is 420 participants, above the 202-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (108% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT00334880, a Phase 3 study of Attention Deficit Hyperactivity Disorder and Attention Deficit Disorders With Hyperactivity, has completed, sponsored by New River Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
420 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of NRP104 administered as a daily morning dose (30, 50, and 70mg/day) compared to placebo in adults (18-55 years of age inclusive) diagnosed with moderate to severe Attention Deficit Hyperactivity Disorder (ADHD).

Interventions

  • DRUG NRP104

Study Locations (20)

California

  • Valley Clinical Research, Inc. - El Centro
  • University of California, Irvine Child Development Center - Irvine
  • Bay Area Research Institute - Lafayette
  • Peninsula Research Associates - Rolling Hills Estate
  • University of California, San Francisco, Dept. of Psychiatry - San Francisco
  • Encompass Clinical Research - Spring Valley

Florida

  • Gulfcoast Clinical Research Center - Fort Myers
  • Miami Research Associates - Miami
  • Clinical Neuroscience Solutions, Inc. - Orlando
  • Meridien Research - Tampa
  • Janus Center for Psychiatric Research LLC - West Palm Beach

Connecticut

  • Yale University School of Medicine - New Haven
  • Psychiatric Medicine Center - New London

Georgia

  • Northwest Behavioral Research Center - Roswell
  • Carman Research - Smyrna

Kansas

  • Psychiatric Associates - Overland Park
  • Vince and Associates Clinical Research - Overland Park

Arkansas

  • Clinical Study Centers, LLC - Little Rock

Colorado

  • Alpine Clinical Research Center - Boulder

Maryland

  • Johns Hopkins at Green Spring Station - Lutherville

Trial Details

FieldValue
Enrollment Target 420 participants
Start Date 2006-05
Est. Completion 2006-11
Phase Phase 3

Sponsor

New River Pharmaceuticals

4 total trials

What the Registry Record Tells You About NCT00334880

The ClinicalTrials.gov registry entry for NCT00334880 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 202-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (108% higher). The listed sponsor is New River Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention - of which NRP104 is the first listed.

NCT00334880 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Connecticut.

Frequently Asked Questions

What is clinical trial NCT00334880 about?

NCT00334880 is a clinical study titled "Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)". The purpose of this study is to evaluate the safety and effectiveness of NRP104 administered as a daily morning dose (30, 50, and 70mg/day) compared to placebo in adults (18-55 years of age inclusive) diagnosed with moderate to severe Attention Deficit Hyperactivity Disorder (ADHD).

What is the current status of trial NCT00334880?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2006-05. Estimated completion is 2006-11.

What conditions does trial NCT00334880 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Hyperactivity Disorders.

What interventions are being tested in trial NCT00334880?

The interventions under investigation include: NRP104 (DRUG).

Who is sponsoring clinical trial NCT00334880?

This trial is sponsored by New River Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00334880 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.