Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556296
|Study Director:||Suma Krishnan||New River Pharmaceuticals|