Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD
Phase of Trial: Phase II
Latest Information Update: 22 Sep 2017
At a glance
- Drugs Amfetamine
- Indications Attention-deficit hyperactivity disorder
- Focus Adverse reactions
- Sponsors Ironshore Pharmaceutical and Development
- 19 Sep 2017 Status changed from active, no longer recruiting to completed.
- 12 Apr 2017 According to an Ironshore Pharmaceutical and Development Media Release, results from this trial were reviewed at an End of Phase 2 meeting with the FDA and based on the feedback company is pursuing for two pivotal Phase 3 studies (see profile 276138 and 269841).
- 12 Apr 2017 According to an Ironshore Pharmaceutical and Development Media Release, results from this trial has been presented to the U.S. Food and Drug Administration.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History