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NCT00735371 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
314
Enrollment target

NCT00735371 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 314 participants.

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The verdict

NCT00735371, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
314 participants
Enrollment target

Study Summary

The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.

Interventions

  • DRUG Placebo
  • DRUG LDX 30 mg
  • DRUG LDX 50 mg
  • DRUG LDX 70 mg

Trial Details

FieldValue
Enrollment Target 314 participants
Start Date 2008-10-08
Est. Completion 2009-04-06
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00735371

The ClinicalTrials.gov registry entry for NCT00735371 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00735371 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00735371 about?

NCT00735371 is a clinical study titled "Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)". The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.

What is the current status of trial NCT00735371?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2008-10-08. Estimated completion is 2009-04-06.

What interventions are being tested in trial NCT00735371?

The interventions under investigation include: Placebo (DRUG), LDX 30 mg (DRUG), LDX 50 mg (DRUG), LDX 70 mg (DRUG).

Who is sponsoring clinical trial NCT00735371?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

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

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.