CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 130 enrolled
Drug / intervention
AMPH ER Tab 5, 10, 15 and 20 mg +1 moredrug
Likely dose
AMPH ER Tab 5, 10, 15 and 20 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/NCT03834766
NCT03834766Phase 3Completed

Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD

Tris Pharma, Inc.·interventional·Posted Feb 8, 2019·Updated Nov 2, 2023

In Brief

A Phase 3 clinical trial evaluating AMPH ER Tab 5, 10, 15 and 20 mg and AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg for ADHD. Completed, enrolled 130 participants across 3 sites.

Detailed Summary

To evaluate the efficacy of AMPH ER TAB compared to placebo in adult patients with ADHD aged 18 to 60 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
CollaboratorsPremier Research

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 8, 2019
Enrollment StartFeb 6, 2019
Primary CompletionOct 19, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.4 years ago

Interventions

AMPH ER Tab 5, 10, 15 and 20 mgdrug

Amphetamine

AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mgdrug

Placebo