Safety of SPD465 in Treating Adults With ADHD.

NCT ID: NCT00152035

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 505 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-10
• Study Completion Date: 2006-11-07

Brief Summary

The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
• Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.

Exclusion Criteria

• Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
• Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
• History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
• Females who are pregnant of lactating.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Other Identifiers

SPD465-304

Identifier Type: -

Identifier Source: org_study_id