Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Shire.
NCT00735371 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 314 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Interventions
- DRUG Placebo
- DRUG LDX 30 mg
- DRUG LDX 50 mg
- DRUG LDX 70 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2008-10-08 |
| Est. Completion | 2009-04-06 |
| Phase | Phase 3 |
What the finished NCT00735371 record still lists
NCT00735371 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00735371 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00735371's enrollment target sits among peer trials
314 1096th of 2000 higher than 900 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03866382 · 314 participants · Phase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
- NCT04500756 · 314 participants · Phase 2
Limiting AAA With Metformin (LIMIT) Trial
- NCT06167746 · 314 participants · Phase 3
iCare4Me Transitions
- NCT06883097 · 314 participants · NA
Quitting Matters Human Immunodeficiency Virus Hybrid Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI