Status:
COMPLETED
Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials
Lead Sponsor:
Noven Therapeutics
Collaborating Sponsors:
Noven Pharmaceuticals, Inc.
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
Detailed Description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of...
Eligibility Criteria
Inclusion
- Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
- Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.
Exclusion
- Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
- Female subject is pregnant or lactating
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00151957
Start Date
October 1 2004
End Date
June 1 2007
Last Update
March 28 2017
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