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NCT03834766 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Tris Pharma.

Completed
Registry status
Phase 3
Development phase
130
Enrollment target

NCT03834766: Completed Phase 3 study, sponsored by Tris Pharma.

NCT03834766 is a Phase 3 study that has completed, run by Tris Pharma. The registered enrollment target is 130 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03834766, a Phase 3 study, has completed, sponsored by Tris Pharma.

COMPLETED
Registry status
Phase 3
Development phase
130 participants
Enrollment target

Study Summary

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

Primary Outcome

The Total Math Score is the sum of the number of math problems attempted plus the number of math problems answered correctly and it provides an objective measure of performance that is time-sensitive, ADHD medication-sensitive, and well documented as a measure to evaluate ADHD medication effectiveness throughout the day. The Total Math Score ranges from 0-800 with higher scores indicating better performance.

Interventions

  • DRUG AMPH ER Tab 5, 10, 15 and 20 mg
  • DRUG AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2019-02-06
Est. Completion 2019-10-19
Phase Phase 3
Tris Pharma

14 total trials

What the finished NCT03834766 record still lists

NCT03834766 is an interventional study that assigns participants to a tested intervention. The registered 130 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 (83% lower).

The record links to 0 conditions, and to 2 interventions - of which AMPH ER Tab 5, 10, 15 and 20 mg is the first listed.

NCT03834766 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03834766 about?

NCT03834766 is a clinical study titled "Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD". To evaluate the efficacy of AMPH ER TAB compared to placebo in adult patients with ADHD aged 18 to 60 years.

What is the current status of trial NCT03834766?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2019-02-06. Estimated completion is 2019-10-19.

What interventions are being tested in trial NCT03834766?

The interventions under investigation include: AMPH ER Tab 5, 10, 15 and 20 mg (DRUG), AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg (DRUG).

Who is sponsoring clinical trial NCT03834766?

This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03834766's enrollment target sits among peer trials

130 1594th of 2000 higher than 404 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

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Source: ClinicalTrials.gov NCT03834766, the US trial registry maintained by the National Library of Medicine. NCT03834766 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.