Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD
|ClinicalTrials.gov Identifier: NCT00556296|
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : June 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: NRP104 Drug: NRp104 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||297 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder|
|Study Start Date :||October 2004|
|Study Completion Date :||September 2005|
NRP104 30mg capsule once daily in a.m.
NRP104 50mg capsule once daily in a.m.
NRP104 70mg capsule once daily in a.m.
|Placebo Comparator: 4||
- Change score from baseline of the ADHD-RS [ Time Frame: 4 weeks ]
- Duration of therapeutic responses using the CPRS ADHD Index [ Time Frame: At treatment endpoint, separately for morning, afternoon and evening responses ]
- Clinical global impression of severity(CGI-S) and improvement (CGI-I) [ Time Frame: Treatment endpoint ]
- Treatment emergent AEs [ Time Frame: 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556296
|Study Director:||Suma Krishnan||New River Pharmaceuticals|