CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 269 enrolled
Drug / intervention
Lisdexamfetamine Dimesylate (LDX)drug
Likely dose
Lisdexamfetamine Dimesylate (LDX) 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00764868
NCT00764868Phase 3Completed
CompareCT.gov

A Phase III, Open-Label, Extension, Multi-Center, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Shire·interventional·Posted Oct 2, 2008·Updated Jun 14, 2021

In Brief

A Phase 3 clinical trial evaluating Lisdexamfetamine Dimesylate (LDX) for ADHD. Completed, enrolled 269 participants across 45 sites.

Detailed Summary

The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2008
Enrollment StartNov 13, 2008
Primary CompletionApr 22, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.8 years ago

Interventions

Lisdexamfetamine Dimesylate (LDX)drug

optimal dose of 30, 50 or 70 mg once daily