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A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00554385
First received: November 5, 2007
Last updated: August 18, 2011
Last verified: August 2011
History of Changes

November 5, 2007
August 18, 2011
November 2007
August 2008   (final data collection date for primary outcome measure)
  • ADHD-RS-IV (HV) [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ] [ Designated as safety issue: No ]
  • CGI-ADHD-S [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ] [ Designated as safety issue: No ]
  • ADHD-RS-IV (HV) [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ]
  • CGI-ADHD-S [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ]
Complete list of historical versions of study NCT00554385 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
The Long-term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study

The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder
Drug: ABT-089
Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.
Other Name: ABT-089
Experimental: 1
Intervention: Drug: ABT-089
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
283
Not Provided
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
  • If female, subject must be practicing at least one method of birth control throughout the study.
  • If female, the result of a pregnancy test is negative.
  • The subject is judged to be in generally good health.

Exclusion Criteria:

  • The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
  • The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
  • The subject has a positive urine drug screen for alcohol or drugs of abuse.
  • The subject anticipates a move outside the geographic area.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00554385
M10-178
Yes
Abbott
Abbott
Not Provided
Study Director: Laura Gault, M.D., Ph.D. Abbott
Abbott
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP