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

NCT03834766 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-11-02

Study results available
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Summary

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

Conditions

  • ADHD

Interventions

DRUG

AMPH ER Tab 5, 10, 15 and 20 mg

Amphetamine

DRUG

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

Placebo

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew J. Cutler, MD · Meridien Research Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2019-10-19
Completion
2019-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834766 on ClinicalTrials.gov