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Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: Methylphenidate + SPD503 (Guanfacine hydrochloride) (Drug); Amphetamine + SPD503 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Shire

Summary

The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17

Clinical Details

Official title: A Phase II, Open-Label Co-Administration Study of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks

Secondary outcome:

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores

Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks

Number of Participants With Improvement on Parent Global Assessment (PGA) Scores

Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with a primary diagnosis of ADHD

- Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for

at least 1 month, with sub-optimal control in the Investigator's opinion

- Male or non-pregnant female subject who agrees to comply with any applicable

contraceptive requirements Exclusion Criteria:

- Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD and mild

anxiety) with significant symptoms

- History of seizure during the last 2 years

- Subject has any specific cardiac condition or family history of significant cardiac

condition

- Subject is pregnant or lactating

Locations and Contacts

Additional Information

FDA recall information

Starting date: August 2004
Last updated: November 25, 2009

Page last updated: August 23, 2015

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